The goal of this study is to identify the genes as well as their association with Nalbuphine. This will help the investigator to identify opioid vulnerability in Pakistani population in the postoperative patients and will contribute to overcoming the opioid crisis, resulting in better and safer outcomes.
Research question is:
Is there any association between the underlying genetic variations and the analgesic efficacy of Nalbuphine in postoperative patients? The Research Objectives are
1. To identify the underlying genes in postoperative patients having pain.
2. To find an association between identified genes and nalbuphine clinical efficacy.
Procedure: After the written informed consent adult men and women will be enrolled in the study. On the day of surgery in the preoperative area, a 5 ml blood sample will be drawn before surgery and will be sent to laboratory for analysis. After routine hemodynamic monitoring in the operative room, general anesthesia will be given including nalbuphine. Standard routine anesthesia monitoring will be done and maintained while monitoring heart rate, ECG, NIBP oxygen saturation, ETCO2 and temperature. Incremental analgesia will be provided whenever needed. After extubation and shifting to recovery room the 2nd sample of blood will be taken and will be sent for analysis. Pain score, nausea vomiting, sedation, requirement of analgesia will be assessed till 24 hours postoperatively.

Start Date01 Sep 2025

Sponsor / Collaborator

Ziauddin University

ChiCTR2500096581

/ SuspendedEarly Phase 1IIT

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-

NCT07009808

/ Not yet recruitingNot ApplicableIIT

Effects of Different Doses of Nalbuphine on Anxiety and Depression in Patients Undergoing Ectopic Pregnancy Surgery: A Prospective, Randomized, Controlled Study

This prospective, randomized, controlled study aims to evaluate the impact of different doses of nalbuphine on anxiety and depression in patients undergoing surgery for ectopic pregnancy. Ectopic pregnancy, which occurs in approximately 2% of all pregnancies, often requires surgical intervention, leading to potential psychological distress such as anxiety and depression in affected women. Effective postoperative pain management is essential to enhance recovery and reduce emotional disturbances.
The study will involve 165 eligible patients diagnosed with ectopic pregnancy at Jinjiang District Maternal and Child Health Hospital. Participants will be randomly assigned to three groups, each receiving a different concentration of nalbuphine combined with metoclopramide for postoperative analgesia. The primary outcome will focus on changes in anxiety and depression scores measured on postoperative day three, while secondary outcomes will assess pain levels, the use of patient-controlled analgesia (PCA), the necessity for rescue analgesics, and the occurrence of adverse reactions.
Sample size calculations suggest that at least 165 participants are required to achieve adequate statistical power. Data will be analyzed using SPSS 25.0 software, with results expected to provide insights into the effectiveness of nalbuphine in improving postoperative recovery and mental health in women experiencing ectopic pregnancy. The study has received ethical approval and is funded by the Chengdu Medical Research Projects (No. 2023465, 2022548, and 2023304).

Start Date20 Jun 2025

Sponsor / Collaborator

Chengdu Jinjiang Maternity & Child Health Hospital

100 Clinical Results associated with Nalbuphine Hydrochloride

100 Translational Medicine associated with Nalbuphine Hydrochloride

100 Patents (Medical) associated with Nalbuphine Hydrochloride

1,592

Literatures (Medical) associated with Nalbuphine Hydrochloride

01 Dec 2025·ANNALS OF MEDICINE

Comparison between butorphanol and nalbuphine for alleviation of catheter-related bladder discomfort and emergence agitation in patients undergoing open spinal surgery: a randomized clinical trial.

Article

Author: Zhou, Qian ; Zheng, Ting ; Wang, Weilian ; Zhang, Kun ; Zhang, Chang ; Dan, Jiapeng

INTRODUCTION:

Opioid receptor agonist/antagonists have positive effects in the management of catheter-related bladder discomfort (CRBD). Whether the differences in κ receptor affinity will have different effects is still unknown. This study aims to compare the efficacy of opioid agents with varying κ receptor affinity profiles in alleviating CRBD and emergence agitation (EA).

PATIENTS AND METHODS:

A total of 120 patients undergoing open spinal surgery were randomly assigned into three groups: saline group, butorphanol group, and nalbuphine group. All drugs were injected intravenously 30 min before the end of surgery. The primary outcomes were the incidence of moderate to severe CRBD and EA at 5 min after tracheal extubation. Secondary outcomes included the severity of CRBD, numerical rating scales (NRS), Richmond agitation-sedation scale (RASS) at five time points after tracheal extubation, the need for rescue analgesia and the incidence of adverse events were also recorded.

RESULTS:

The incidence of moderate to severe CRBD was significantly lower in group B compared to group C (p < 0.001) at all the time points. Group B had significantly fewer patients with severe CRBD and lower NRS scores than both groups C and N (p < 0.001) at T1 and T2. Group B had lower RASS scores than groups N and C at T1, while at T2, T3 and T4, groups B and N continued to exhibit significantly lower NRS scores compared to group C (p < 0.001). The requirement for rescue analgesia decreased sequentially from group C to group N and then to group B (p < 0.001). The incidence of EA was significantly lower in groups B and N than in group C (p < 0.001).

CONCLUSIONS:

Opioid receptor agonist/antagonists demonstrate efficacy in preventing CRBD and EA without significant adverse events. Butorphanol exhibits superior efficacy to nalbuphine in the early postoperative period.

01 Nov 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

A novel ultrasensitive derivatization-free synchronous fluorescence approach for the simultaneous analysis of propofol and nalbuphine in human plasma and dosage forms: Compliance with greenness and blueness metrics

Article

Author: Magdy, Galal ; El-Maghrabey, Mahmoud ; Mansour, Fotouh R ; Alshehri, Sultan ; Al-Khateeb, Lateefa A ; Radwan, Aya Saad ; El Hamd, Mohamed A ; Alsehli, Bandar R ; Mahdi, Wael A

This study presents a very sensitive and eco-friendly synchronous spectrofluorimetric method for the simultaneous quantification of propofol (PRP) and nalbuphine (NAL) for the first time. The technique used the intrinsic fluorescence characteristics of the two drugs, providing enhanced sensitivity and specificity. The two drugs were assessed simultaneously at 217 nm and 281 nm for PRP and NAL, respectively, with a synchronous wavelength difference (Δλ) of 80 nm. The proposed method was validated according to ICH Q2 (R2) requirements, exhibiting satisfactory accuracy, precision, linearity, and selectivity within the designated concentration ranges. The concentrations exhibited linearity within the ranges of 15.0-300.0 ng/mL and 0.5-16.0 µg/mL, with detection limits of 2.67 ng/mL and 0.15 µg/mL for PRP and NAL, respectively. The developed approach, owing to its great sensitivity, was utilized to assess the examined drugs in human plasma samples. The results demonstrated good bioanalytical applicability, exhibiting high recovery percentages (98.40-101.70) and low relative standard deviation (%RSD) values (<1.66). The proposed method was applied to accurately analyze the cited drugs in their ampoule dosage forms with great selectivity. The MoGAPI and AGREE metricsdemonstrated the method's exceptional eco-friendliness and sustainability. Additionally, the BAGI tool was employed to assess the method's economic viability, applicability, and practicality. The three tools demonstrated the sustainability and feasibility of the developedapproach, as well as its appropriateness for the routine analysis of the examined drugs. The developed method represents the first analytical technique for the concurrent estimation of PRP and NAL without the necessity for toxic reagents, excessive organic solvents, or complicated instruments. The method is derivatization-free and does not require complicated sample treatment or lengthy extraction procedures. The suggested method's excellent sensitivity, simplicity, speed, environmental friendliness, and cost-effectiveness make it appropriate for therapeutic drug monitoring of the studied drugs.

15 Aug 2025·MEDICINE

Optimization of postoperative pain management in gynecological laparoscopic surgery with combined Nalbuphine and Remifentanil: A retrospective analysis with propensity score matching

Article

Author: Jin, Chunnv ; Lv, Lin ; Cao, Xiangru ; Huang, Shaohua

Postoperative pain management is a critical aspect of perioperative care for patients undergoing gynecological laparoscopic surgery. The efficacy of different drug combinations in alleviating postoperative pain varies. Investigating the effects of Nalbuphine, Remifentanil, and their combination on postoperative pain can help optimize anesthesia protocols for these patients. This retrospective study analyzed data from 840 patients who underwent gynecological laparoscopic surgery, divided into a Nalbuphine group (n = 184), a Remifentanil group (n = 456), and a Nalbuphine–Remifentanil combination group (n = 200). Baseline and intraoperative data were collected. Patients were divided into 2 groups based on their 6-hour postoperative visual analog scale (VAS) score (VAS ≥ 5 and VAS < 5). A univariate logistic regression analysis was conducted on the selected factors and drug groups, followed by the construction of 3 multivariate logistic regression models. Model 1 included the selected factors, Model 2 added the drug groups, and Model 3 applied propensity score matching (PSM) based on Model 2. The area under the curve (AUC) of the receiver operating characteristic curve was used to assess the performance of the 3 models. Univariate logistic regression analysis indicated that surgical type, American Society of Anesthesiologists Physical Status Classification System (ASA) score, respiratory rate, and drug group were significantly associated with postoperative pain. Model 1 showed that ASA score, respiratory rate, and surgical type were independent factors for postoperative pain. Model 2, which included the drug groups, identified ASA score, surgical type, and drug groups (combination therapy vs single therapy) as independent factors for postoperative pain. In Model 3, after PSM, ASA score, surgical type, and drug groups remained significant independent factors. Receiver operating characteristic curve analysis demonstrated that Model 3 (AUC = 0.719) had better predictive performance than Model 2 (AUC = 0.674) and Model 1 (AUC = 0.659). This study showed that ASA score, surgical type, and drug group were key independent factors influencing postoperative pain in gynecological laparoscopic surgery patients. The combination of Nalbuphine and Remifentanil more effectively alleviated postoperative pain. Model 3, after PSM, exhibited improved predictive performance, suggesting a potential advantage of combination therapy in managing postoperative pain in these patients.

114

News (Medical) associated with Nalbuphine Hydrochloride

07 Aug 2025

·www.prnewswire.com

Trevi Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Updates

Announced positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF Closed $115 million underwritten offering with expected cash runway into 2029 Management to host a conference call and webcast today at 4:30 p.m. ET   NEW HAVEN, Conn., Aug. 7, 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), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced financial results for the quarter ended June 30, 2025, and provided business updates.  "The recently received full data set from our CORAL trial for chronic cough in patients with IPF bolsters the statistically-significant topline results presented in June. This data marks a major milestone for Trevi as it shows consistency and clinically meaningful benefit for these patients," said Jennifer Good, President and CEO of Trevi Therapeutics. "Chronic cough is a debilitating and underserved condition for patients with IPF, and these results, along with the positive RCC data from our RIVER trial announced earlier this year, reinforce our belief in Haduvio's potential to transform care of chronic cough and the lives of these patients. We expect our current cash and investments to provide us with cash runway into 2029, giving us the financial strength to advance Haduvio through late-stage development and several key clinical milestones, as well as enabling pre-commercial planning activities." Second Quarter 2025 Financial Results and Recent Business Highlights  Positive topline results from the Phase 2b CORAL trial evaluating Haduvio for the treatment of chronic cough in patients with IPF (N=165) were announced in June 2025. 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 statistically-significant 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%.1 The Company plans to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025 to align on the Phase 3 program. The Company is preparing to initiate the Phase 3 program in the first half of 2026. Additional analyses from the Phase 2b CORAL trial showed positive results with Haduvio on the Leicester Cough Questionnaire (LCQ) Total Score for the 108 mg BID and 54 mg BID dose groups, increasing the LCQ score by 3.4 points (p=0.01) and 3.7 points (p=0.01), respectively. A 1.3-point increase from Baseline is considered clinically meaningful. The LCQ is considered an important measure of quality of life for patients suffering from chronic cough. Completed a $115 million underwritten offering in June 2025, enabling continued advancement of Haduvio's clinical programs. The Company ended the second quarter of 2025 with $203.9 million in cash, cash equivalents and marketable securities, with expected cash runway into 2029. Second Quarter 2025 Financial Highlights Research and development (R&D) expenses: R&D expenses for the second quarter of 2025 decreased to $9.4 million from $10.0 million in the same period in 2024, primarily due to decreased clinical development expenses for the Company's Phase 2a RIVER trial, Human Abuse Potential (HAP) study, and Phase 2b CORAL trial, all of which were actively enrolling patients in the prior year period. These decreases were partially offset by increased costs for the Company's recently initiated Phase 1 drug-drug interaction study, and personnel and related expenses. General and administrative (G&A) expenses: G&A expenses for the second quarter of 2025 increased to $4.3 million from $3.3 million in the same period in 2024, primarily due to an increase in professional fees, and personnel and related expenses. Other Income, net: Other Income, net for the second quarter of 2025 increased to $1.4 million from $0.9 million in the same period in 2024, primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances. Net loss: For the second quarter of 2025, the Company reported a net loss of $12.3 million compared to the net loss of $12.4 million in the same period in 2024. 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:   August 11-13: Stifel's 2025 Biotech Summer Summit September 3-5: Wells Fargo 2025 Healthcare Conference September 3-5: Cantor Global Healthcare Conference 2025 September 8-10: H.C. Wainwright & Co. 27th Annual Global Investment Conference September 8-10: Morgan Stanley 23rd Annual Global Healthcare Conference September 17-19: 2025 Leerink Partners Biopharma Summit September 27-October 1: European Respiratory Society (ERS) Congress 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), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in chronic cough patients with IPF and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.    Chronic cough is a highly prevalent condition, impacting up to 85% of patients with IPF. There are ~150,000 patients in the U.S. with IPF. 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 March 31, 2025 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] 1 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. 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

Phase 2Clinical ResultFinancial Statement

01 Jul 2025

·www.prnewswire.com

Trevi Therapeutics to Attend Leerink Partners Therapeutics Forum: I&I and Metabolism

NEW HAVEN, Conn., July 1, 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 in patients with refractory chronic cough (RCC), today announced that Jennifer Good, President and Chief Executive Officer, and Lisa Delfini, Chief Financial Officer, will be attending Leerink Partners Therapeutics Forum: I&I and Metabolism, held from July 8-9 in Boston, Massachusetts. 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 in patients with refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials of patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough is a highly prevalent condition, impacting up to 85% of patients with IPF. There are ~150,000 patients in the U.S. with IPF. 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. Investor Contact  Katie Barrett  Trevi Therapeutics, Inc.  (203) 903 9627  [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

05 Jun 2025

·www.prnewswire.com

Trevi Therapeutics Announces Closing of $115 Million Underwritten Offering and Full Exercise by Underwriters of Option to Purchase Additional Shares

NEW HAVEN, Conn., June 5, 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 in patients with refractory chronic cough (RCC), today announced the closing of its previously announced underwritten public offering of 20,010,000 shares of its common stock at a public offering price of $5.75 per share, which includes 2,610,000 additional shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock in the public offering at the public offering price, less underwriting discounts and commissions. The total proceeds of the public offering were approximately $115.1 million, before deducting underwriting discounts and commissions and expenses payable by Trevi. All of the shares in the offering were sold by Trevi. Morgan Stanley, Leerink Partners, Stifel and Cantor acted as joint book-running managers for the offering. The shares were offered by Trevi pursuant to a shelf registration statement on Form S-3 (File No. 333-273030), which was filed with the Securities and Exchange Commission (SEC) on June 29, 2023, amended on August 11, 2023 and declared effective by the SEC on August 15, 2023. This offering was made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. The final terms of the offering are disclosed in a final prospectus supplement which has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, New York 10022, or by email at [email protected]. This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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 in patients with refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. 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

100 Deals associated with Nalbuphine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00843	Nalbuphine Hydrochloride	N02AF02	DB00844

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anesthesia	United States	PH HEALTH	15 May 1979
Pain	United States	PH HEALTH	15 May 1979

Developing

10 top R&D records.

to view more data

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
Moderate pain	Phase 1	China	Yichang Humanwell Pharmaceuticals Co., Ltd.	31 Aug 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03497975 (PRISM \| PRISM study, CTgov)	Phase 2/3	prurigo nodularis \| Pruritus	353	Nalbuphine ER Tablets (NAL ER)	cplzjuktpg = ojlwoggkba eofjvukrpj (fqcsoqiklg, ayvyxfhdpd - sbbrctsnfs) View more	-	24 Jun 2025
				Placebo Tablets+Nalbuphine ER Tablets (Placebo)	cplzjuktpg = ccudvtssoo eofjvukrpj (fqcsoqiklg, klhkkwylcm - yhsnfdysep) View more
PRNewswire Manual	Not Applicable	Chronic cough	-	Placebo	kowxpjlokd(thjgbjkedt) = mipdwpytka ordekidkdt (zmqsgdfrlz ) View more	Positive	03 Dec 2024
				IV Butorphanol 6mg	kowxpjlokd(thjgbjkedt) = tncqxzpwzu ordekidkdt (zmqsgdfrlz ) View more
NCT02820051 (CTgov)	Not Applicable	Sedation	102	Transcutaneous CO2 monitor+Midazolam+Lidocaine+nalbuphine (Midazolam)	cuzkabflfw(lewkzbyfnr) = ztrtfpxmkj jmngjiytlu (xasxlbvgii, 7.5) View more	-	02 Dec 2024
				Transcutaneous CO2 monitor+propofol+Lidocaine+nalbuphine (Propofol)	cuzkabflfw(lewkzbyfnr) = skjhymhbtz jmngjiytlu (xasxlbvgii, 9.6) View more
NCT05041270 (ZU-IRB#:7045-15-8-2021, Pubmed \| BMC Anesthesiol)	Not Applicable	-	69	Bupivacaine + Normal Saline	qhyjfelvcz(rkvbdkywvd) = lgkfqzangw qegdcnoxcp (gslywzpiis ) View more	Positive	06 Dec 2023
				Bupivacaine + Nalbuphine	qhyjfelvcz(rkvbdkywvd) = eyjytdftoq qegdcnoxcp (gslywzpiis ) View more
NCT03497975 (PRISM, EADV2023) Manual	Phase 2/3	prurigo nodularis	247	Haduvio	mxousqhboa(gkogshdibk) = phkohorinn djmnujofyz (uvkmuqfujg ) View more	Positive	13 Oct 2023
ATS2023	Not Applicable	Chronic cough	-	Nalbuphine ER	yxshzrqote(geovsfzvbb) = 61% of patients treated with nalbuphine ER improved, 21% had no change, and 18% worsened, compared with 18%, 68%, and 14%, respectively, of patients receiving placebo gcaevpkkma (agqinprkdb ) View more	-	21 May 2023
				Placebo
NCT03059511 (Pubmed \| Arch Dis Child)	Phase 1	-	52	Intranasal nalbuphine	gfalquwqkp(bjkrhbzkrt) = hkmqqqbfzy kjsldxdaty (irapqjagvy )	-	13 Sep 2022
				Intravenous nalbuphine	gfalquwqkp(bjkrhbzkrt) = vfhhxsjcek kjsldxdaty (irapqjagvy )
NCT03497975 (PRISM study, EADV2022)	Phase 2/3	prurigo nodularis	-	Oral Nalbuphine Extended-Release 162 mg	ouqsiplpxj(hnbfyonubn) = bqpvzojldo aticewzwoz (uaddhmyenc )	Positive	07 Sep 2022
				Placebo	ouqsiplpxj(hnbfyonubn) = qnremnwdtb aticewzwoz (uaddhmyenc )
ERS2022	Phase 2	Idiopathic Pulmonary Fibrosis	45	NAL ER 27 mg once daily	ctdmvbzvbt(bonyssaikb) = lwmjgbwmth bxbjrtmwip (ckokctwbmh )	Positive	04 Sep 2022
NCT03497975 (PRISM, Corporate Publications) Manual	Phase 2/3	prurigo nodularis	344	Haduvio	kzymfgfobc(hetedkxmgr) = cicfqkaghm gtffmxfods (upgsqxbyex ) View more	Positive	29 Jun 2022
				Placebo	kzymfgfobc(hetedkxmgr) = ddufecilud gtffmxfods (upgsqxbyex ) View more

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