Optimization of the Efficacy and Safety of Nalbuphine Combined with Esketamine for Post-Cesarean Analgesia: A Randomized, Double-Blind, Parallel-Controlled Clinical Study

Start Date01 Jul 2025

Sponsor / Collaborator-

CTRI/2025/03/082843

/ Not yet recruitingPhase 4

Comparison of nalbuphine and dexmedetomidine as an adjuvant to 0.5% ropivacaine in USG guided supraclavicular plexus block in upper limb surgeries: A randomised double blind prospective study. - NIL

Start Date30 Apr 2025

Sponsor / Collaborator-

ChiCTR2500100023

/ SuspendedNot ApplicableIIT

Clinical study on the efficacy and safety of nalbuphine combined with cyclopropofol in painless endoscopic examination of patients with liver cirrhosis

Start Date07 Apr 2025

Sponsor / Collaborator

Shanghai Public Health Clinical Center

100 Clinical Results associated with Nalbuphine Hydrochloride

100 Translational Medicine associated with Nalbuphine Hydrochloride

100 Patents (Medical) associated with Nalbuphine Hydrochloride

1,796

Literatures (Medical) associated with Nalbuphine Hydrochloride

01 Apr 2025·OBESITY SURGERY

Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Patients with Morbid Obesity Undergoing Bariatric Surgery: A Randomized Controlled Trial

Article

Author: Amin, Sarah ; Hasanin, Ahmed ; Zakaria, Dina ; Abdallah, Ahmed S ; Soliman, Suzy ; Abdelkader, Amr ; Mostafa, Maha

Abstract:

Background:

We aimed to compare the perioperative analgesic efficacy of intravenous ibuprofen versus ketorolac in patients with obesity undergoing bariatric surgery.

Methods:

This randomized controlled trial included adult patients with obesity undergoing bariatric surgery. Participants were randomized to receive either ibuprofen or ketorolac intravenously every 8 h. All patients received paracetamol intravenously 1 gm/6 h. Inadequate intraoperative analgesia was managed by fentanyl boluses, while inadequate postoperative analgesia was managed by nalbuphine boluses. The primary outcome was static visual analogue scale (VAS) 0.5 h postoperatively. Secondary outcomes were postoperative static and dynamic VAS, intra- and postoperative opioids consumption, postoperative nausea and vomiting, and patients’ satisfaction.

Results:

Fifty-three patients were analyzed in each group. The median VAS (quartiles) at 0.5 h postoperatively was lower in the ketorolac group (3 [3, 6]) than in the ibuprofen group (7 [4, 8]), P-value < 0.001. The static and dynamic VAS were lower in the ketorolac group than in the ibuprofen group up to 6 h postoperatively. The intra- and postoperative opioid consumption was lower in the ketorolac group than in the ibuprofen group. The incidence of postoperative nausea and vomiting was also lower in the ketorolac group than in the ibuprofen group. Patients in the ketorolac group had higher level of satisfaction than patients in the ibuprofen group.

Conclusion:

In patients with obesity undergoing bariatric surgery, perioperative administration of ketorolac provided improved pain control, reduced opioid consumption, and lowered the risk of postoperative nausea and vomiting, compared to ibuprofen. Additionally, patients reported higher satisfaction with ketorolac.

01 Apr 2025·JCPSP-Journal of the College of Physicians and Surgeons Pakistan

The Optimal Dosage of the Nalbuphine Preemptive Analgesia on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised, Controlled, Double-Blind Study

Article

Author: Wang, Honghua ; Chen, Peng ; Liu, Dajin ; Jing, Xu

OBJECTIVE:

To investigate the optimal dosage of nalbuphine preemptive analgesia on pain after laparoscopic cholecystectomy.

STUDY DESIGN:

A double-blind, randomised study. Place and Duration of the Study: Department of Anaesthesiology, The Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an Second Hospital, Jiangsu Province, China, from 2020 to 2023.

METHODOLOGY:

This study enrolled 240 patients requiring elective laparoscopic cholecystectomy. Patients were randomly allocated into four groups receiving placebo (Group NS) or nalbuphine 0.1 mg/kg (Group N1) or 0.2 mg/kg (Group N2) or 0.3 mg/kg (Group N3) intravenously 15 minutes before surgery. The postoperative visual analogue scale (VAS) score, and the rescue analgesic requirement within 72 hours after surgery were evaluated. One-way analysis of variance and a non-parametric Kruskal-Wallis test were used to compare differences between the groups.

RESULTS:

The VAS scores at rest and on movement were significantly lower in the N2 and N3 groups compared to the placebo group at 4, 12, 24, and 48 hours after surgery (p <0.05). Moreover, the VAS scores of the N2 group were significantly lower than N1 and N3 groups. The first rescue analgesia time was significantly longer (p <0.05), and the rescue analgesic requirements were considerably reduced in the N2 group than in the placebo group (p <0.05).

CONCLUSION:

Nalbuphine preemptive analgesia provided effective analgesia in patients undergoing laparoscopic cholecystectomy. The results showed that the optimal dose was 0.2 mg/kg for nalbuphine preemptive analgesia in laparoscopic cholecystectomy.

KEY WORDS:

Nalbuphine, Preemptive analgesia, Laparoscopic cholecystectomy, Postoperative pain, Rescue analgesia, VAS score.

01 Apr 2025·Korean Journal of Pain

Comparison of ultrasound-guided superior trunk block versus clavipectoral fascial plane block for clavicular surgery: a double-blind, randomized controlled trial

Article

Author: Fahmy, Ahmed Mohammad ; Mohamed, Mohamed Gaber ; Medhat, Marwa Mohamed

Background:

This study compared the quality and duration of analgesia between the superior trunk (ST) and the clavipectoral fascial plane (CFP) blocks in conjunction with a selective supraclavicular nerve (SCN) block for clavicular surgeries.

Methods:

Fifty patients undergoing mid-third clavicular procedures were randomly assigned to the ST group (received an SCN block followed by blockage of the ST of the brachial plexus) and the CFP group (received an SCN block followed by the CFP block). The primary outcome was the time until the first rescue analgesia. Secondary outcomes included total nalbuphine dosage and numerical rating scale (NRS) scores within the first 24 hours, the onset of sensory block, as well as deltoid and biceps muscle function using the modified Bromage score (MBS), diaphragmatic excursion, along with satisfaction levels.

Results:

The ST group exhibited a more prolonged duration until the first request for rescue analgesia compared to the CFP group (18.76 ± 0.89 hours vs. 15.34 ± 1.38 hours), with a mean difference of 3.42 hours (95% confidence interval: 2.76 to 4.08, P < 0.001). The ST group consumed less nalbuphine and reported lower NRS scores at 6, 8, 12, 16, and 24 hours than the CFP group. Additionally, the ST group exhibited a lower MBS and diaphragmatic excursion than the CFP group. However, the differences in the onset of sensory block and satisfaction levels were not statistically significant.

Conclusions:

The ST group demonstrated superior outcomes in pain control with less favorable outcomes concerning diaphragmatic excursion and upper limb motor function.

104

News (Medical) associated with Nalbuphine Hydrochloride

18 Mar 2025

·www.prnewswire.com

Trevi Therapeutics Reports Fourth Quarter and Year End 2024 Financial Results and Provides Business Updates

Announced positive topline data from the Phase 2a RIVER trial in patients with refractory chronic cough (RCC), making Haduvio the first therapy in clinical development to show benefit in patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and RCC Completed enrollment in the Phase 2b CORAL trial in IPF patients with chronic cough in February 2025, with topline data expected in the second quarter of 2025 Announced positive outcome from sample size re-estimation in the Phase 2b CORAL trial, resulting in no change to study sample size Ended 2024 with $107.6 million in cash, cash equivalents and marketable securities, with expected cash runway into the second half of 2026 Management to host a conference call and webcast today at 4:30 p.m. ET NEW HAVEN, Conn., March 18, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced financial results for the quarter and year ended December 31, 2024, and provided business updates. "Trevi had three positive and meaningful clinical data read-outs over the past few months validating the strategy of developing Haduvio as a potential best-in-class therapy for chronic cough conditions," said Jennifer Good, President and CEO of Trevi Therapeutics. "With Haduvio, we are looking to address a significant unmet need across chronic cough conditions where there are no therapies approved in the U.S. Haduvio has the unique potential to work across various chronic cough conditions due to its central and peripheral mechanism. We look forward to our expected readout of topline results for the Phase 2b CORAL trial in IPF chronic cough patients in the second quarter of this year." Fourth Quarter and Recent Business Highlights Positive topline data in the Phase 2a RIVER trial for the treatment of patients with RCC (N=66) in March 2025. Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a 57% placebo-adjusted change from baseline and showed similar effects in patients with moderate or severe cough counts. The Company plans to discuss next steps and future study design with the FDA. Positive sample size re-estimation (SSRE) outcome for the Phase 2b CORAL trial for the treatment of chronic cough in patients with IPF in December 2024. The SSRE reaffirmed the conditional power assumptions and the original sample size (N=160). The trial completed enrollment in February 2025 and topline data is expected in the second quarter of 2025. Positive topline results from the Human Abuse Potential study of oral nalbuphine in December 2024. Oral nalbuphine had a statistically significant lower "Drug Liking" for the clinical dose range vs. the active comparator as well as secondary endpoint results that were consistent with the primary endpoint supporting the known profile of nalbuphine and its currently unscheduled status. Completed a $50 million underwritten offering in December 2024 to support the continued development of Haduvio. Ended 2024 with $107.6 million in cash, cash equivalents and marketable securities, with expected cash runway into the second half of 2026. Fourth Quarter 2024 Financial Highlights Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2024 increased to $9.3 million from $6.5 million in the same period in 2023, primarily due to increased clinical development expenses for the Phase 2b CORAL trial, the Phase 2a RIVER trial, and the HAP study, as well as an increase in personnel-related expenses. General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2024 increased to $2.9 million from $2.4 million in the same period in 2023, primarily due to an increase in stock-based compensation expense and personnel-related expenses. Other income, net: Other income, net was $0.8 million in the fourth quarter of 2024 compared to $1.1 million in the same period of 2023. The decrease was primarily due to lower cash equivalent and marketable securities balances and lower interest rate yields. Net loss: For the fourth quarter of 2024, the Company reported a net loss of $11.4 million, compared to a net loss of $7.8 million in the same period in 2023. Full Year 2024 Financial Highlights R&D expenses: R&D expenses for the year ended December 31, 2024, were $39.4 million compared to $23.7 million in 2023. The increase was primarily due to increased clinical development expenses for the Phase 2b CORAL trial, the Phase 2a RIVER trial, the HAP study, and the Phase 1b TIDAL study, as well as an increase in personnel-related expenses and stock-based compensation expense. These increases were partially offset by decreased clinical development expenses for our Phase 2b/3 PRISM trial. G&A expenses: G&A expenses for the year ended December 31, 2024, were $12.1 million compared to $10.2 million in 2023. The increase was primarily due to an increase in personnel-related expenses, stock-based compensation expense, information technology service costs and market research costs. Other income, net: Other income, net was $3.6 million for the year ended December 31, 2024, compared to $4.8 million 2023. The decrease was primarily due to a decrease in interest income due to lower cash equivalent and marketable securities balances. Net loss: For the year ended December 31, 2024, the Company reported a net loss of $47.9 million, compared to a net loss of $29.1 million in the same period in 2023. Conference Call/Webcast To participate in the live conference call by phone, please dial (877) 870 4263 (domestic) or (412) 317 0790 (international) and ask to join the Trevi Therapeutics call. No code is necessary for access. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at . An archived replay of the webcast will also be available for 30 days on the Company's website following the event. Upcoming Meetings The Company plans to participate in the following events: April 7-10: 24th Annual Needham Virtual Healthcare Conference April 8-10: Jones 2025 Healthcare & Technology Summit April 16-17: Piper Sandler Spring Biopharma Symposium About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio is the first and only therapy in clinical development to show a statistically significant reduction in chronic cough across patients with both IPF and RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough is a highly prevalent condition in IPF patients, impacting up to 85% of the IPF population. There are ~140,000 U.S. IPF patients and the impact of chronic cough is significant with patients coughing up to 1,500 times per day. This consistent cough and any associated damage may lead to worsening disease, a higher risk of progression, death, or need for lung transplant. Chronic cough also often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in patients with IPF and current off-label treatment options provide minimal benefit to patients. Refractory chronic cough has no approved therapies in the U.S. and is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip) and includes unexplained chronic cough. RCC affects ~2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is a highly debilitating disease and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. For more information, visit and follow Trevi on X (formerly Twitter) and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, expectations regarding Trevi's uses and sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Jonathan Carlson Trevi Therapeutics, Inc. (203) 654 3286 [email protected] Media Contact Rosalia Scampoli 914-815-1465 [email protected] SOURCE Trevi Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementClinical ResultPhase 2

10 Mar 2025

·endpts.com

Trevi’s mid-stage chronic cough data meet ‘home run’ scenario, stock soars

Trevi Therapeutics’ chronic cough drug reduced patients’ 24-hour cough frequency by 57% compared to placebo in a Phase 2a trial, exceeding investors’ expectations. The company’s stock $TRVI soared 40% at market open as a result. Leerink analysts said the data hit a “home run scenario,” noting that the candidate, named Haduvio, showed similar efficacy in patients with both moderate and severe cough at baseline. In the RIVER study, patients with severe cough at baseline saw a 66% reduction in 24-hour cough frequency after taking the treatment, while those in the moderate cough group had a 68% reduction (both with a p-value of less than 0.0001). Haduvio is an oral extended-release version of an old pain medicine called nalbuphine. According to Trevi, the drug works on opioid receptors that play a role in controlling cough hypersensitivity. Nalbuphine is not currently considered a controlled substance , which refers to a drug or substance regulated by the government because of its potential for abuse or addiction. A Trevi spokesperson told Endpoints News that the company doesn’t expect Haduvio to be scheduled as a controlled substance. In its news release, the company said that there were no treatment-emergent serious adverse events. The company plans on discussing its next steps with the FDA and expects to initiate the next study with the agency’s input. “The competitive landscape in the last couple of years has thinned out due to multiple failures,” Trevi’s CEO Jennifer Good said on a Monday morning call with investors. “With the strength of the RIVER data and the sparse competitive landscape, we believe Haduvio has the potential to be best-in-class in patients with RCC.” RCC refers to refractory chronic cough, or a persistent cough lasting more than eight weeks that isn’t resolved by standard treatments. There are currently no approved treatments for RCC. Trevi’s main competitor in RCC is GSK’s Phase 3 candidate camlipixant, which was a focal point of its $2 billion Bellus acquisition in 2023. The company is set to read out late-stage results in the second half of this year. While it is nearly impossible to compare data across trials, recently published Phase 2b camlipixant results showed a placebo-adjusted reduction in 24-hour cough rate of 34% in patients who experienced 25 or more coughs per hour at baseline. Trevi classified severe cough as patients who experience 20 or more coughs per hour. Trevi made clear that idiopathic pulmonary fibrosis, a chronic lung disease, is still its priority for Haduvio. The company expects to have Phase 2b results in IPF patients with chronic cough in the second quarter.

Phase 2Clinical ResultPhase 3Acquisition

10 Mar 2025

·www.prnewswire.com

Trevi Therapeutics Announces Positive Topline Results from the Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough

Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a 57% placebo-adjusted change from baseline Haduvio showed similar efficacy in patients with moderate or severe cough counts (p<0.0001) Haduvio is the first and only therapy to show a statistically-significant reduction in chronic cough across both RCC and IPF patients Patient reported and other secondary outcomes were statistically significant and consistent with the primary endpoint Company to host a conference call and webcast today at 8:30 a.m. ET and will be joined by key opinion leader, Professor Jacky Smith NEW HAVEN, Conn., March 10, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), is pleased to announce today positive topline results from its Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66). Haduvio met the primary endpoint with a statistically-significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis (p<0.0001). "I am happy to share these robust positive results from our Phase 2a RIVER trial in refractory chronic cough which has been a difficult-to-treat indication with no approved therapies in the U.S.," said Jennifer Good, President and Chief Executive Officer of Trevi Therapeutics. "The RIVER trial demonstrated that Haduvio was highly effective, and worked quickly at the lowest dose tested across a broad range of cough counts. These results, coupled with our existing IPF chronic cough results, are further evidence of the effectiveness of Haduvio's central and peripheral KAMA mechanism in treating these difficult neurological cough conditions which are so disruptive to patients' lives." James Cassella, Ph.D., Chief Development Officer of Trevi Therapeutics added, "The results from the RIVER trial were highly statistically significant with consistent outcomes across the primary and analyzed secondary endpoints as well as for patients with moderate or severe baseline cough frequency. We look forward to advancing development of nalbuphine ER in the hopes of providing relief for the significant unmet need for these chronic cough patients. Based on these results, we plan to discuss next steps with the FDA and anticipate initiating the next study after we receive their input. Thank you to all the patients and investigators who contributed to our trials and continue to advance clinical research to find a treatment for chronic cough." "I am excited to see the positive results from the Phase 2a RIVER trial and the potential role nalbuphine ER could have in therapy for RCC patients," said Professor Jacky Smith, Professor of Respiratory Medicine at the University of Manchester. "RCC significantly impacts patients' lives both physically and psychologically, resulting in chest pain, urinary incontinence, depression, exhaustion, dizziness and much more. Therapies are desperately needed as patients continue to suffer from this debilitating disease." The Phase 2a Refractory Chronic Cough Improvement Via Nalbuphine ER (RIVER) trial was a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety and tolerability of Haduvio for the treatment of patients with RCC. Each treatment period lasted 21 days, separated by a 21-day washout period. During the Haduvio treatment period, patients were titrated with assessments at 27 mg twice daily (BID), 54 mg BID and 108 mg BID, with objective cough and other assessments at each dose. The primary endpoint of the trial was the mean change in 24-hour cough frequency, as determined by an objective cough monitor, for the full analysis set (FAS) population at Day 21. The FAS population included all patients who received at least one dose of study drug and have objective cough count data on both Baseline and Day 21 in at least one treatment period. Primary Endpoint Additional Endpoints Haduvio demonstrated a statistically-significant reduction in 24-hour cough frequency of 66% in the severe cough (20+ coughs/hour) subgroup (p<0.0001) and 68% in the moderate cough (10-19 coughs/hour) subgroup (p<0.0001). 84% of Haduvio patients had at least a 30% reduction in 24-hour cough frequency vs. baseline, as compared to 29% of placebo patients, a difference of 55% (p<0.0001). A statistically-significant reduction in 24-hour cough frequency, as measured by an objective cough monitor, was seen as early as Day 7 (27 mg BID) for patients on Haduvio (p<0.0001). Patients on Haduvio experienced a statistically-significant improvement in patient reported outcomes compared to placebo as early as Day 7 (27 mg BID) in the Cough Severity Visual Analog Scale and the Patient-Reported Cough Frequency. The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials. The most common adverse events experienced included: constipation, nausea, somnolence, headache, dizziness, and fatigue and there were no treatment emergent serious adverse events. Conference Call The Company will host a conference call and webcast to review the topline results today, March 10th, at 8:30 a.m. ET. The live webcast, including audio and presentation slides, will be accessible at the time of the meeting and can be accessed here. To participate in the conference call by phone, please dial (877) 870 4263 (domestic) or (412) 317 0790 (international) and ask to join the Trevi Therapeutics call. No code is necessary for access. An archived replay of the webcast will also be available for 30 days on the Company's website following the event. About Refractory Chronic Cough (RCC) Refractory chronic cough has no approved therapies in the U.S. and is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip) and includes unexplained chronic cough. RCC affects ~2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is a highly debilitating disease and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough is highly prevalent in IPF patients, impacting up to 85% of the IPF population. There are ~140,000 U.S. IPF patients and the impact of chronic cough is significant with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to worsening disease, a higher risk of progression, death, or need for lung transplant. Chronic cough also often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in patients with IPF and current off-label treatment options provide minimal benefit to patients. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. For more information, visit and follow Trevi on X (formerly Twitter) and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans with respect to clinical trials and clinical data, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries, as well as other risks and uncertainties set forth in Trevi's quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Jonathan Carlson Trevi Therapeutics, Inc. (203) 654 3286 [email protected] Media Contact Rosalia Scampoli 914-815-1465 [email protected] SOURCE Trevi Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2

100 Deals associated with Nalbuphine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D00843	Nalbuphine Hydrochloride	N02AF02	DB00844

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	United States	Endo Operations Ltd.	15 May 1979
Pain	United States	Endo Operations Ltd.	15 May 1979

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Analgesia	Phase 3	China	Yichang Humanwell Pharmaceuticals Co., Ltd.	09 Oct 2023
Respiratory Insufficiency	Phase 3	China	Yichang Humanwell Pharmaceuticals Co., Ltd.	30 Aug 2023
prurigo nodularis	Phase 3	United States	Trevi Therapeutics, Inc.	01 Mar 2015
prurigo nodularis	Phase 3	Germany	Trevi Therapeutics, Inc.	01 Mar 2015
prurigo nodularis	Phase 3	Poland	Trevi Therapeutics, Inc.	01 Mar 2015
Pruritus	Phase 3	Germany	Trevi Therapeutics, Inc.	01 Mar 2015
Uremic pruritus	Phase 3	United States	Trevi Therapeutics, Inc.	01 Jun 2014
Uremic pruritus	Phase 3	Poland	Trevi Therapeutics, Inc.	01 Jun 2014
Uremic pruritus	Phase 3	Romania	Trevi Therapeutics, Inc.	01 Jun 2014
Chronic cough	Phase 2	Australia	Trevi Therapeutics, Inc.	06 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PRNewswire Manual	Not Applicable	Chronic cough	-	Placebo	orbolbmeco(aephrfyhks) = dedqrdiogm vdyxcwzwnt (zocqnysway ) View more	Positive	03 Dec 2024
				IV Butorphanol 6mg	orbolbmeco(aephrfyhks) = zjyuphhlci vdyxcwzwnt (zocqnysway ) View more
NCT02820051 (CTgov)	Not Applicable	Sedation	102	Transcutaneous CO2 monitor+Midazolam+Lidocaine+nalbuphine (Midazolam)	rpvjxtsvqt(tsvzuwfzae) = jytnumbgkm ffhifaocag (dvrfinxaxa, 7.5) View more	-	02 Dec 2024
				Transcutaneous CO2 monitor+Propofol+Lidocaine+nalbuphine (Propofol)	rpvjxtsvqt(tsvzuwfzae) = jyeihhdyeb ffhifaocag (dvrfinxaxa, 9.6) View more
NCT05041270 (ZU-IRB#:7045-15-8-2021, Pubmed \| BMC Anesthesiol)	Not Applicable	-	69	Bupivacaine + Normal Saline	ffyudxctcb(cajinfpjjk) = nwunzdjoqg ukyjmzdagl (hvuvmcbxfo ) View more	Positive	06 Dec 2023
				Bupivacaine + Nalbuphine	ffyudxctcb(cajinfpjjk) = xvfarlcjnl ukyjmzdagl (hvuvmcbxfo ) View more
NCT03497975 (PRISM, EADV2023) Manual	Phase 2/3	prurigo nodularis	247	Haduvio	erkamsktks(kkbcxymfro) = wzaosmqyzg jbqqgopicp (sbgdmhfqgp ) View more	Positive	13 Oct 2023
NCT04030026 (CANAL, Corporate Publications) Manual	Phase 2	Idiopathic Pulmonary Fibrosis \| Chronic cough	38	Haduvio	yhrwlqxkxh(noqmtuklau) = wffyfoqkwb gtyqytvkdm (emzchhkzke ) View more	Positive	19 Sep 2022
				Placebo	yhrwlqxkxh(noqmtuklau) = ovcegdjish gtyqytvkdm (emzchhkzke ) View more
NCT03059511 (Pubmed \| Arch Dis Child)	Phase 1	-	52	Intranasal nalbuphine	wdftrighgc(hsuhdtcwwc) = vdvfdjlqqn diwxtsopcr (xzigekansh )	-	13 Sep 2022
				Intravenous nalbuphine	wdftrighgc(hsuhdtcwwc) = blljcjpxyh diwxtsopcr (xzigekansh )
NCT03497975 (PRISM study, EADV2022)	Phase 2/3	prurigo nodularis	-	Oral Nalbuphine Extended-Release 162 mg	xhemroonnl(fgyjdhnnhb) = wsrizvqrhh wznqnvsfiv (divjpsnwfr )	Positive	07 Sep 2022
				Placebo	xhemroonnl(fgyjdhnnhb) = svwxjthbkf wznqnvsfiv (divjpsnwfr )
ERS2022	Phase 2	Idiopathic Pulmonary Fibrosis	45	NAL ER 27 mg once daily	nwknybdiwt(dahedqhaxp) = vodulxrixm zlfukwpqvo (jqhtvryvff )	Positive	04 Sep 2022
NCT03497975 (PRISM, Corporate Publications) Manual	Phase 2/3	prurigo nodularis	344	Haduvio	kegsxcfyrq(yvzthljnfk) = rhffsmbvhs avzviwcbpo (pfbqaelmnu ) View more	Positive	29 Jun 2022
				Placebo	kegsxcfyrq(yvzthljnfk) = jnabmdcytq avzviwcbpo (pfbqaelmnu ) View more
NCT04030026 (CANAL, Biospace) Manual	Phase 2	Idiopathic Pulmonary Fibrosis \| Chronic cough	26	Haduvio	tpvkebznfw(ieluxexjov) = wukpuqyjiq xkbztiqamr (wkryyfqjbz )	Positive	24 Feb 2022
				Placebo	tpvkebznfw(ieluxexjov) = stnetdcrfe xkbztiqamr (wkryyfqjbz )

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