{"id":3300,"date":"2024-01-09T16:14:54","date_gmt":"2024-01-09T16:14:54","guid":{"rendered":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/?page_id=3300"},"modified":"2025-12-25T17:29:39","modified_gmt":"2025-12-25T17:29:39","slug":"previous-clinical-trials","status":"publish","type":"page","link":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/previous-clinical-trials\/","title":{"rendered":"Previous Clinical Trials"},"content":{"rendered":"

[et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” _builder_version=”4.16″ background_color=”#f2faff” use_background_color_gradient=”on” background_color_gradient_stops=”rgba(0,67,106,0.49) 0%|rgba(0,67,106,0.51) 100%” background_color_gradient_overlays_image=”on” background_color_gradient_start=”rgba(0,67,106,0.49)” background_color_gradient_end=”rgba(0,67,106,0.51)” background_image=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2022\/10\/Research-2-1-e1664822070425.png” custom_padding=”50px|0px|50px|0px|true|false” custom_padding_tablet=”20px||20px||true|false” custom_padding_phone=”20px||20px||true|false” da_disable_devices=”off|off|off” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row custom_padding_last_edited=”on|phone” _builder_version=”4.16″ custom_padding=”36px|0px|36px|0px|true|false” custom_padding_tablet=”” custom_padding_phone=”0px||0px||true|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” admin_label=”Video Title Section” _builder_version=”4.16″ background_color=”#FFFFFF” background_image=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2018\/10\/Nalbuphine_chem_web_widebkgrnd_rightalign.jpg” custom_padding=”30px|0px|30px|0px|true|false” custom_padding_tablet=”30px||30px||true|false” custom_padding_phone=”30px||30px||true|false” da_disable_devices=”off|off|off” box_shadow_style=”preset1″ saved_tabs=”all” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”|800|||||||” header_text_color=”#00436A” header_font_size=”35px” header_line_height=”1.3em” header_2_font=”Muli|800|||||||” header_2_text_color=”#00436a” header_2_font_size=”35px” header_2_line_height=”1.2em” header_3_font=”|300|||||||” header_3_text_color=”#00436A” header_3_font_size=”25px” header_3_line_height=”1.3em” custom_margin=”0px||2px|||” custom_padding=”0px||20px” header_font_size_tablet=”” header_font_size_phone=”30px” header_font_size_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Previous Clinical Trial Results<\/strong><\/h1>\n

Haduvio\u2122 (oral nalbuphine ER) achieved statistically significant reductions in cough frequency in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC).<\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” global_colors_info=”{}”]We are currently developing Haduvio to help patients suffering from serious chronic cough conditions. We completed a Phase 2b trial in patients with IPF suffering from chronic cough and a Phase 2a trial in patients with RCC. We are planning for future trials in these patient populations as well as in patients with non-IPF interstitial lung disease who experience chronic cough. All trials are expected to initiate by the first half of 2026.\u00a0[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” admin_label=”Coffee Menu” _builder_version=”4.16″ background_color=”#3e596b” background_blend=”soft-light” custom_padding=”30px||30px||true|false” custom_padding_tablet=”30px||30px||true|false” custom_padding_phone=”30px||30px||true|false” da_disable_devices=”off|off|off” box_shadow_style=”preset6″ global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row _builder_version=”4.16″ custom_padding=”50px|0px|50px|0px|true|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_number_counter number=”85″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_number_counter][et_pb_text _builder_version=”4.16″ header_font=”||||||||” header_2_font=”Muli|800||on|||||” header_2_text_color=”#7db2ce” header_2_font_size=”34px” header_2_line_height=”1.3em” header_3_font=”||||||||” custom_margin=”||0px” custom_padding=”||20px” global_colors_info=”{}”]<\/p>\n

of IPF Patients Experience Chronic Cough<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” admin_label=”Coffee Menu” _builder_version=”4.16″ background_color=”#FFFFFF” background_blend=”soft-light” custom_padding=”54px||54px||true|false” custom_padding_tablet=”30px||30px||true|false” custom_padding_phone=”30px||30px||true|false” da_disable_devices=”off|off|off” box_shadow_style=”preset6″ global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_padding=”||6px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/07\/CORAL_wordmark_color_logo_RGB-100-300×150.jpg” title_text=”CORAL_wordmark_color_logo_RGB-100″ _builder_version=”4.27.4″ _module_preset=”default” width=”23%” width_tablet=”34%” width_phone=”66%” width_last_edited=”on|phone” module_alignment=”center” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”Muli||||||||” header_2_text_color=”#00436A” header_2_font_size=”30px” header_2_line_height=”1.2em” header_3_font=”Muli||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||2px|||” custom_padding=”0px||20px” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Phase 2b Cough Reduction with Nalbuphine ER (CORAL) Trial<\/h2>\n

In June 2025, we announced positive results from our Phase 2b CORAL trial for the treatment of chronic cough in patients with Idiopathic Pulmonary Fibrosis (IPF). The results from this trial supported the previous positive results seen in the Phase 2a CANAL<\/a><\/span>\u00a0trial for this same population.<\/span><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ disabled_on=”on|on|off” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/07\/CORAL-Relative-Change-from-Baseline-at-Week-6-scaled.png” title_text=”CORAL Relative Change from Baseline at Week 6″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ text_font_size=”10px” text_line_height=”1.6em” header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]Haduvio (nalbuphine ER\/NAL ER) is an investigational drug
\nmITT population
\nPrimary efficacy analysis conducted on log-transformed cough frequency data
\n^One placebo patient with an extreme outlier value at Week 6 was excluded from the modified intent-to-treat mITT population. Inclusion of the patient in the placebo group would have resulted in an increased cough frequency from baseline in the placebo group and much greater placebo-adjusted differences.
\nPBO: placebo[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Statistically Significant Difference vs Placebo At All Doses<\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Haduvio met the primary endpoint with statistically significant reductions in 24-hour cough frequency across all dose groups. The 108 mg BID, 54 mg BID and 27 mg BID dose groups achieved reductions from Baseline of 60.2% (p<0.0001), 53.4% (p<0.0001), and 47.9% (p<0.01), respectively, compared to a placebo reduction from Baseline of 16.9%^.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|on” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Statistically Significant Difference vs Placebo At All Doses<\/h3>\n

[\/et_pb_text][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/07\/CORAL-Relative-Change-from-Baseline-at-Week-6-scaled.png” title_text=”CORAL Relative Change from Baseline at Week 6″ _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||2px|||” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ text_font_size=”10px” text_line_height=”1.6em” header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]Haduvio (nalbuphine ER\/NAL ER) is an investigational drug
\nmITT population
\nPrimary efficacy analysis conducted on log-transformed cough frequency data
\n^One placebo patient with an extreme outlier value at Week 6 was excluded from the modified intent-to-treat mITT population. Inclusion of the patient in the placebo group would have resulted in an increased cough frequency from baseline in the placebo group and much greater placebo-adjusted differences.
\nPBO: placebo[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Haduvio met the primary endpoint with statistically significant reductions in 24-hour cough frequency across all dose groups. The 108 mg BID, 54 mg BID and 27 mg BID dose groups achieved reductions from Baseline of 60.2% (p<0.0001), 53.4% (p<0.0001), and 47.9% (p<0.01), respectively, compared to a placebo reduction from Baseline of 16.9%^.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”on|on|off” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Broad Response<\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Majority of patients achieved at least a 50% reduction in objective cough frequency. A 50% reduction in 24-hour cough frequency at Week 6 vs Baseline was seen in 65% of patients on 108 mg BID\u00a0Haduvio (p<0.001), 63% of patients on 54 mg BID Haduvio (p<0.001) and 60% of patients on 27 mg BID Haduvio (p<0.001) dose groups, compared to 19% of placebo patients.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/07\/CORAL-Response-Thresholds-for-24hr-Cough-Frequency.png” title_text=”CORAL Response Thresholds for 24hr Cough Frequency” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ text_font_size=”10px” text_line_height=”1.6em” header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

mITT population, Primary efficacy analysis conducted on log-transformed cough frequency data.
^One placebo patient with an extreme outlier value at Week 6 was excluded from the modified intent-to-treat (mITT) population. Inclusion of the patient in the placebo group would have resulted in an increased cough frequency from baseline in the placebo group and much greater placebo-adjusted differences.
Responder is defined those subjects meeting the pre-specified threshold.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|on” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Broad Response<\/h3>\n

[\/et_pb_text][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/07\/CORAL-Response-Thresholds-for-24hr-Cough-Frequency.png” title_text=”CORAL Response Thresholds for 24hr Cough Frequency” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||3px|||” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ text_font_size=”10px” text_line_height=”1.6em” header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

mITT population, Primary efficacy analysis conducted on log-transformed cough frequency data.
^One placebo patient with an extreme outlier value at Week 6 was excluded from the modified intent-to-treat (mITT) population. Inclusion of the patient in the placebo group would have resulted in an increased cough frequency from baseline in the placebo group and much greater placebo-adjusted differences.
Responder is defined those subjects meeting the pre-specified threshold.<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

 <\/p>\n

Majority of patients achieved at least a 50% reduction in objective cough frequency. A 50% reduction in 24-hour cough frequency at Week 6 vs Baseline was seen in 65% of patients on 108 mg BID\u00a0Haduvio (p<0.001), 63% of patients on 54 mg BID Haduvio (p<0.001) and 60% of patients on 27 mg BID Haduvio (p<0.001) dose groups, compared to 19% of placebo patients.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ disabled_on=”on|on|off” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/07\/CORAL-Relative-Change-from-Baseline-in-24hr-Cough-Frequency.png” title_text=”CORAL Relative Change from Baseline in 24hr Cough Frequency” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ text_font_size=”10px” text_line_height=”1.6em” header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]mITT population, Primary efficacy analysis conducted on log-transformed cough frequency data
\n^One placebo patient with an extreme outlier value at Week 6 was excluded from the modified intent-to-treat (mITT) population. Inclusion of the patient in the placebo group would have resulted in an increased cough frequency from baseline in the placebo group and much greater placebo-adjusted differences.
\nResponder is defined those subjects meeting the pre-specified threshold[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Rapid Onset of Effect<\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]A rapid reduction was seen in 24-hour cough frequency at Week 2 with\u00a0Haduvio, the first time point measured.[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|on” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Rapid Onset of Effect<\/h3>\n

[\/et_pb_text][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/07\/CORAL-Relative-Change-from-Baseline-in-24hr-Cough-Frequency.png” title_text=”CORAL Relative Change from Baseline in 24hr Cough Frequency” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||5px|||” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ text_font_size=”10px” text_line_height=”1.6em” header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]mITT population, Primary efficacy analysis conducted on log-transformed cough frequency data
\n^One placebo patient with an extreme outlier value at Week 6 was excluded from the modified intent-to-treat (mITT) population. Inclusion of the patient in the placebo group would have resulted in an increased cough frequency from baseline in the placebo group and much greater placebo-adjusted differences.
\nResponder is defined those subjects meeting the pre-specified threshold[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”19px||19px||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]A rapid reduction was seen in 24-hour cough frequency at Week 2 with\u00a0Haduvio, the first time point measured.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” disabled_on=”off|off|off” admin_label=”Coffee Menu” _builder_version=”4.27.4″ background_color=”#EBEAEA” background_blend=”soft-light” custom_padding=”54px||54px||true|false” custom_padding_tablet=”30px||30px||true|false” custom_padding_phone=”30px||30px||true|false” da_disable_devices=”off|off|off” box_shadow_style=”preset6″ global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_padding=”||6px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/02_wordmark_color-300×131.png” title_text=”02_wordmark_color” _builder_version=”4.27.4″ _module_preset=”default” width=”23%” width_tablet=”34%” width_phone=”66%” width_last_edited=”on|phone” module_alignment=”center” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”Muli||||||||” header_2_text_color=”#00436A” header_2_font_size=”30px” header_2_line_height=”1.2em” header_3_font=”Muli||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||2px|||” custom_padding=”0px||20px” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Phase 2a R<\/b>efractory Chronic Cough\u00a0<\/span>I<\/b>mprovement\u00a0<\/span>V<\/b>ia Nalbuphine\u00a0<\/span>ER<\/b>\u00a0(<\/span>RIVER) Trial<\/span><\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

In March 2025, we announced positive results from our Phase 2a RIVER trial in patients with RCC, including patients with unexplained chronic cough. The results from this trial supported Haduvio\u2019s potential in treating chronic cough across indications through both the objective cough monitor and patient reported outcomes.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ disabled_on=”on|on|off” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/RIVER-Primary-Endpoint-2.png” title_text=”RIVER Primary Endpoint” force_fullwidth=”on” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”][\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Statistically Significant Primary Endpoint<\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Haduvio met the primary endpoint with a statistically-significant reduction in 24-hour cough frequency with a 67% reduction from baseline (p<0.0001), and a 57% placebo-adjusted change.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|on” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Statistically Significant Primary Endpoint<\/h3>\n

[\/et_pb_text][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/RIVER-Primary-Endpoint-2.png” title_text=”RIVER Primary Endpoint” force_fullwidth=”on” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”23px||19px||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Haduvio met the primary endpoint with a statistically-significant reduction in 24-hour cough frequency with a 67% reduction from baseline (p<0.0001), and a 57% placebo-adjusted change.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”on|on|off” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Rapid Reduction in Cough Frequency<\/strong><\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Haduvio demonstrated a statistically significant reduction in 24-hour cough at Day 7 (27 mg BID), the earliest objective cough reading with the lowest assessed dose.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/RIVER-Relative-Change-from-Baseline.png” title_text=”RIVER Relative Change from Baseline” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|on” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Rapid Reduction in Cough Frequency<\/h3>\n

[\/et_pb_text][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/RIVER-Relative-Change-from-Baseline.png” title_text=”RIVER Relative Change from Baseline” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” custom_margin=”||3px|||” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”23px||19px||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Haduvio demonstrated a statistically significant reduction in 24-hour cough at Day 7 (27 mg BID), the earliest objective cough reading with the lowest assessed dose.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ disabled_on=”on|on|off” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/RIVER-Responder-Analysis.png” title_text=”RIVER Responder Analysis” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Broad Clinically Meaningful Effect<\/strong><\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

84% <\/strong>of those treated with Haduvio saw a clinically meaningful reduction in their 24-hour cough frequency compared to 29% of those treated with placebo. 77% of Haduvio treated patients achieved a 50% or greater reduction in their cough frequency compared with 15% on Placebo.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|on” _builder_version=”4.27.4″ _module_preset=”default” border_width_bottom=”2px” border_color_bottom=”#EBEAEA” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Broad Clinically Meaningful Effect<\/h3>\n

[\/et_pb_text][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/RIVER-Responder-Analysis.png” title_text=”RIVER Responder Analysis” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” custom_margin=”||5px|||” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”19px||19px||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

84% <\/strong>of those treated with Haduvio saw a clinically meaningful reduction in their 24-hour cough frequency compared to 29% of those treated with placebo. 77% of Haduvio treated patients achieved a 50% or greater reduction in their cough frequency compared with 15% on Placebo.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|off” _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”||3px|||” border_width_bottom=”2px” border_color_bottom=”RGBA(255,255,255,0)” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_text_color=”#00436A” header_2_font=”||||||||” header_2_text_color=”#000000″ header_2_font_size=”24px” header_2_line_height=”1.2em” header_3_font=”||||||||” header_3_text_color=”#00436A” header_3_line_height=”1.6em” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Consistency Across Baseline Cough Frequency <\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”5px||19px|||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding=”11px|||||” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Haduvio demonstrated a statistically-significant reduction in 24-hour cough frequency with a placebo adjusted change of 51% in the severe cough (20+ coughs\/hour) subgroup (p<0.0001) and 75% in the moderate cough (10-19 coughs\/hour) subgroup (p<0.0001).<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/RIVER-Baseline-Cough-Analysis.png” title_text=”RIVER Baseline Cough Analysis” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” custom_margin=”||2px|||” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-content\/uploads\/2025\/04\/RIVER-Baseline-Cough-Analysis_Time.png” title_text=”RIVER Baseline Cough Analysis_Time” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” custom_margin=”||2px|||” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” da_disable_devices=”off|off|off” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ header_3_text_color=”#00436A” custom_margin=”15px|||||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Safety<\/h3>\n

Over 1,000 patients have been dosed with Haduvio across various indications with\u00a0some patients treated for up to 1-year.<\/p>\n

The safety results of the CORAL and RIVER trials were generally consistent with the known safety profile of Haduvio from previous trials.<\/p>\n

Adverse events most commonly observed during the CORAL trial included nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence and dry mouth. Serious adverse events (all non-fatal) were reported for four patients (10.0%) in the placebo group and for two patients (1.6%) across all Haduvio doses combined.<\/p>\n

Adverse events most commonly observed during the RIVER trial were constipation, nausea, somnolence, headache, dizziness, and fatigue and there were no treatment emergent serious adverse events.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” disabled_on=”off|off|off” admin_label=”Video Title Section” _builder_version=”4.27.4″ background_color=”#7DB2CE” background_enable_image=”off” background_position=”bottom_center” custom_padding=”30px|0px|30px|0px|true|false” custom_padding_tablet=”30px||30px||true|false” custom_padding_phone=”30px||30px||true|false” background_last_edited=”on|desktop” use_background_color_gradient_phone=”on” background_color_gradient_stops_phone=”rgba(255,255,255,0.93) 0%|rgba(255,255,255,0.99) 100%” background_color_gradient_start_phone=”rgba(255,255,255,0.93)” background_color_gradient_end_phone=”rgba(255,255,255,0.99)” background_enable_image_phone=”off” da_disable_devices=”off|off|off” box_shadow_style=”preset1″ saved_tabs=”all” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row disabled_on=”off|off|off” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_signup mailchimp_list=”Trevi Clinical Trials|0fbaa347f0″ first_name_field=”off” last_name_field=”off” title=”Clinical Trials” description=”<\/p>\n

We are planning future trials for the treatment of chronic cough in patients with IPF, non-IPF interstitial lung disease, and patients with RCC.<\/p>\n

To be notified about clinical trial opportunities with Haduvio, join our mailing list.<\/p>\n

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Previous Clinical Trial Results Haduvio\u2122 (oral nalbuphine ER) achieved statistically significant reductions in cough frequency in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC).We are currently developing Haduvio to help patients suffering from serious chronic cough conditions. We completed a Phase 2b trial in patients with IPF suffering from […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-3300","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-json\/wp\/v2\/pages\/3300","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-json\/wp\/v2\/comments?post=3300"}],"version-history":[{"count":68,"href":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-json\/wp\/v2\/pages\/3300\/revisions"}],"predecessor-version":[{"id":4031,"href":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-json\/wp\/v2\/pages\/3300\/revisions\/4031"}],"wp:attachment":[{"href":"https:\/\/s2.designcostaging.com\/clients\/trevitherapeutics-staging\/wp-json\/wp\/v2\/media?parent=3300"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}