Effect of patient-controlled intravenous analgesia with nalbuphine combined with sufentanil on gastrointestinal function recovery after laparoscopic colorectal surgery A single-center, prospective, randomized controlled study was conducted

Start Date20 Feb 2025

Sponsor / Collaborator-

NCT06818396

/ Not yet recruitingNot ApplicableIIT

Analgesic Efficacy of Fascia Iliaca Compartment Block Compared With Intrathecal Nalbuphine for Hip Surgery Under Spinal Anesthesia: a Randomized Controlled Trial

It is already known that fascia iliaca compartment block and intrathecal nalbuphine are very effective ways in postoperative pain control in patients having hip surgeries.

Start Date18 Feb 2025

Sponsor / Collaborator

Ain Shams University

TCTR20241130002

/ Not yet recruitingPhase 4IIT

The efficacy of intrathecal nalbuphine for postoperative pain control in lumbar spine surgery: A double-blind randomized control trial.

Start Date01 Feb 2025

Sponsor / Collaborator

Navamindradhiraj University

100 Clinical Results associated with Nalbuphine Hydrochloride

100 Translational Medicine associated with Nalbuphine Hydrochloride

100 Patents (Medical) associated with Nalbuphine Hydrochloride

1,782

Literatures (Medical) associated with Nalbuphine Hydrochloride

01 Mar 2025·Minerva Anestesiologica

Analgesic effect of lateral femoral cutaneous nerve block added to the pericapsular nerve group (PENG) block in primary total hip arthroplasty: a randomized clinical trial

Article

Author: Fortuna-Costa, Anneliese ; Garcia, Luis V ; Cardoso, Fabricio A

BACKGROUND:

Adequate hip joint and surgical incision analgesia represent a challenge in the postoperative period of primary total hip arthroplasty (THA). This study aimed to evaluate whether the combination of the lateral femoral cutaneous nerve block (LFCN block) and the pericapsular nerve group block (PENG block) influences postoperative analgesia and rescue opioids, in primary THA surgeries.

METHODS:

A trial was proposed with 74 patients for THA surgeries under spinal anesthesia, where 37 received PENG block (GPENG) and the other 37, PENG block and LFCN block (GPENG+LFC). The primary outcome was the presence and intensity of pain at rest and on movement, using the Numeric Rating Scale. The secondary main outcome was the total consumption of opioids. The follow-up was 48 h.

RESULTS:

Significantly fewer patients reported pain in the GPENG+LFC compared to GPENG: at rest, at 4 h (17 [45.95%] vs. 28 [75.68%] respectively, P=0.088), 12 h (4 [10.81%] vs. 17 [45.95%] respectively, P=0.016), and 24 h (4 [10.81%] vs. 13 [35.14%] respectively, P=0.0252); on movement, at 4 h (17 [45.95%] vs. 30 [81.08%] respectively, P=0.0002), 12 h (4 [10.81%] vs. 19 [51.35%] respectively, P=0.0003), and 24 h (5 [13.51%] vs. 14 [37.84%] respectively, P=0.0166). Total opioid consumption was significantly lower in GPENG+LFC compared to GPENG up to 48 hours postoperatively (1200 mg of tramadol and 6 mg of nalbuphine vs. 2400 mg and 21 mg respectively, P=0.0188).

CONCLUSIONS:

The combination of the LFCN block and the PENG block, compared to the sole PENG block, results in better analgesia at rest and on movement up to 24 h and a reduction in the total consumption of opioids up to 48 h after THA.

01 Mar 2025·ANESTHESIA AND ANALGESIA

A Randomized, Controlled Trial of Palonosetron Versus Ondansetron for Nausea, Vomiting, and Pruritus in Cesarean Delivery with Intrathecal Morphine

Article

Author: Sukumpanumet, Wasin ; Sriprajittichai, Pin ; Worravitudomsuk, Tarvit ; Charuluxananan, Somrat

BACKGROUND::

Spinal anesthesia is the preferred anesthetic technique for cesarean deliveries. Postoperative nausea and vomiting (PONV) and pruritus occur in up to 80% and 83% of patients, respectively, after cesarean delivery with intrathecal opioids. Ondansetron is the recommended medication for PONV prophylaxis, but palonosetron, a second-generation 5-HT3 receptor antagonist, has a higher receptor affinity and a longer half-life. However, studies on palonosetron use in cesarean deliveries are limited. This study aimed to determine whether palonosetron was more effective than ondansetron in preventing intrathecal morphine-induced PONV and pruritus in cesarean deliveries.

METHODS::

Parturients who underwent cesarean delivery under spinal anesthesia were randomized into 3 groups: P (palonosetron 0.075 mg), O (ondansetron 4 mg), and N (normal saline). The study drug was intravenously administered after the umbilical cord was clamped. The primary outcome measures were the 48-hour incidence of PONV and pruritus. The secondary outcome measures were the PONV and pruritus scores at the postanesthesia care unit (PACU) and ward, rescue medications, satisfaction scores, and adverse events. Ordinal data were analyzed using the Kruskal-Wallis test. Continuous and categorical data were analyzed using a 1-way analysis of variance, Kruskal-Wallis test, and Pearson’s χ2 test, respectively. A value of P < .05 was considered significant. Post hoc analysis pairwise comparisons with Bonferroni correction were also performed.

RESULTS::

Overall, 300 parturients were enrolled, and 297 parturients completed the study. One patient in the P group and 2 in the O group were excluded because of conversion to general anesthesia after failed spinal anesthesia. The baseline patient characteristics were comparable between the groups. The PONV incidence rates in the P, O, and N groups were 26.3% (95% confidence interval [CI], 17.4–35.1), 34.7% (95% CI, 25.1–44.3), and 50.0% (95% CI, 40.0–59.9), respectively (P = .002). The incidence rates of pruritus in the P, O, and N groups were 69.7% (95% CI, 60.5–78.9), 76.5% (95% CI, 67.9–85.1), and 87.0% (95% CI, 80.3–93.7), respectively (P = .013). Pairwise comparisons revealed significantly lower incidences of PONV and pruritus in the P group than in the N group (P < .001 and P = .003, respectively). However, no significant differences were observed between the P and O groups or between the O and N groups. Additionally, the P group required significantly less nalbuphine rescue for pruritus than the N group (P = .004 and P = .005 for the PACU and ward, respectively). PONV rescue, satisfaction scores, and adverse events were not significantly different among the 3 groups.

CONCLUSIONS::

Palonosetron effectively prevents intrathecal morphine-induced PONV and pruritus during cesarean delivery. However, the efficacy of palonosetron is not significantly different from that of ondansetron.

31 Jan 2025·JOURNAL OF WILDLIFE DISEASES

COMPARISON OF BUTORPHANOL-AZAPERONE-MEDETOMIDINE AND NALBUPHINE-MEDETOMIDINE-AZAPERONE FOR IMMOBILIZATION OF WHITE-TAILED DEER (ODOCOILEUS VIRGINIANUS)

Article

Author: D'Angelo, Gino J. ; Muller, Lisa I. ; Osborn, David A. ; Ruder, Mark G. ; Grunwald, Patrick J. ; Goode, Kaitlin O.

Butorphanol-azaperone-medetomidine (BAM) is commonly used for white-tailed deer (Odocoileus virginianus) immobilization in captive and free-ranging populations. It is a federally regulated controlled substance requiring stringent regulatory compliance, complicating field application. A prescription-only drug combination, nalbuphine-medetomidine-azaperone® (NalMed-A) provides a less-regulated alternative for use by wildlife professionals. Efficacy and safety of these drug combinations for immobilization of deer have not been compared in a controlled trial, and reports of dose-specific effects of NalMed-A on white-tailed deer physiology are lacking. Additionally, residual effects of these drugs on deer behavior, food consumption, and stress response have not been reported. In February through April 2021, we immobilized 30 captive female, adult white-tailed deer in three treatment groups (n=10 each). Hand-injected doses were 1.5 mL BAM intramuscularly (IM; 41.0 mg butorphanol, 13.6 mg azaperone, 16.4 mg medetomidine), 1.5 mL NalMed-A IM (60.0 mg nalbuphine, 15.0 mg medetomidine, 15.0 mg azaperone), and 2.0 mL NalMed-A IM (80.0 mg nalbuphine, 20.0 mg medetomidine, 20.0 mg azaperone). We compared quality of immobilizations and reversals and times to induction and reversal among treatments, collected biological samples to measure stress hormones and blood gases, and conducted observations to determine treatment-related variations in behaviors. When an effective dose was administered, both BAM and NalMed-A produced rapid and smooth immobilization and recovery after reversal. All treatments in combination with manual restraint caused some degree of hyperthermia, hypoxemia, hypercarbia, bradycardia, respiratory and metabolic acidosis, and elevated lactate and serum cortisol. At 60 d, all deer were still alive, with no apparent residual effects. Vital signs of deer exposed to manual restraint and these drug combinations should be monitored closely, with supportive therapy provided when needed. We suggest BAM and NalMed-A are safe for immobilizing deer in situations similar to our trials, although doses may perform differently in deer remotely injected without manual restraint.

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	United States	Trevi Therapeutics, Inc.	01 Mar 2015
Pruritus	Phase 3	Germany	Trevi Therapeutics, Inc.	01 Mar 2015
Pruritus	Phase 3	Poland	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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PRNewswire Manual	Not Applicable	Chronic cough	-	Placebo	eqntecyeug(khimdxmuzd) = cvkabhbbdx blgkrjbljx (lycegeeodf ) View more	Positive	03 Dec 2024
				IV Butorphanol 6mg	eqntecyeug(khimdxmuzd) = yyptpubeyd blgkrjbljx (lycegeeodf ) View more
NCT02820051 (CTgov)	Not Applicable	Sedation	102	Transcutaneous CO2 monitor+Midazolam+Lidocaine+nalbuphine (Midazolam)	lrlefenoyu(jliojpbkbe) = nqgflaaohv efdqzfptao (xixbcsywyb, 7.5) View more	-	02 Dec 2024
				Transcutaneous CO2 monitor+Propofol+Lidocaine+nalbuphine (Propofol)	lrlefenoyu(jliojpbkbe) = nrjmanuqxj efdqzfptao (xixbcsywyb, 9.6) View more
NCT05041270 (ZU-IRB#:7045-15-8-2021, Pubmed \| BMC Anesthesiol)	Not Applicable	-	69	Bupivacaine + Normal Saline	zdwhqqkmil(ntelndompd) = fpewfxetmx adsuklqnhq (xakysnuofh ) View more	Positive	06 Dec 2023
				Bupivacaine + Nalbuphine	zdwhqqkmil(ntelndompd) = nnkxolniut adsuklqnhq (xakysnuofh ) View more
NCT03497975 (PRISM, EADV2023) Manual	Phase 2/3	prurigo nodularis	247	Haduvio	wqeacvpcaq(ktxlovopcx) = csbiezckvk dmbwcxmano (uxlydvgxhn ) View more	Positive	13 Oct 2023
NCT04030026 (CANAL, Corporate Publications) Manual	Phase 2	Idiopathic Pulmonary Fibrosis \| Chronic cough	38	Haduvio	sbtxzxouuo(yfpwkadofj) = qarnxykcie larhqhhlvq (vbcjqnlhwx ) View more	Positive	19 Sep 2022
				Placebo	sbtxzxouuo(yfpwkadofj) = mfkhqjymkq larhqhhlvq (vbcjqnlhwx ) View more
NCT03059511 (Pubmed \| Arch Dis Child)	Phase 1	-	52	Intranasal nalbuphine	ixmstvlydx(jnoctveeap) = wxojfwtfbw gbgqlajmob (eaoxcgjppg )	-	13 Sep 2022
				Intravenous nalbuphine	ixmstvlydx(jnoctveeap) = cylfmtengl gbgqlajmob (eaoxcgjppg )
NCT03497975 (PRISM study, EADV2022)	Phase 2/3	prurigo nodularis	-	Oral Nalbuphine Extended-Release 162 mg	qhubhkyygj(wfhjgeoxmn) = srvtzuvzts ygtdtiqevo (nqkrtszohv )	Positive	07 Sep 2022
				Placebo	qhubhkyygj(wfhjgeoxmn) = usnysjtnqs ygtdtiqevo (nqkrtszohv )
ERS2022	Phase 2	Idiopathic Pulmonary Fibrosis	45	NAL ER 27 mg once daily	fqgithghzu(fiwwngsbxn) = mqgjdvuqnz drxuradjcq (kmmgkknfsb )	Positive	04 Sep 2022
NCT03497975 (PRISM, Corporate Publications) Manual	Phase 2/3	prurigo nodularis	344	Haduvio	zqdzmojiqe(hdbfptthuh) = pyshwcecqy djwpvetqzh (clbkajhnuf ) View more	Positive	29 Jun 2022
				Placebo	zqdzmojiqe(hdbfptthuh) = frqedzyjke djwpvetqzh (clbkajhnuf ) View more
NCT04030026 (CANAL, Biospace) Manual	Phase 2	Idiopathic Pulmonary Fibrosis \| Chronic cough	26	Haduvio	uvhfufrwcx(mhawaloxgc) = kpakipfwxl valhaibewy (ovfmkdgtbf )	Positive	24 Feb 2022
				Placebo	uvhfufrwcx(mhawaloxgc) = nvwnhanbea valhaibewy (ovfmkdgtbf )

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