Nalbuphine

Trevi Therapeutics Announces Results from Phase 2b/3 PRISM Open-Label Extension Study of Haduvio™ in Prurigo Nodularis

Retrieved on: 
Friday, October 13, 2023
Congress, European Academy of Allergy and Clinical Immunology, OLE, Vomiting, BID, Dermatology, Nalbuphine, IPF, Prurigo nodularis, Somnolence, Nausea, Idiopathic pulmonary fibrosis, FDA, Therapy, Chronic cough, Itch, Fatigue, Dizziness, PRISM, Patient, Pharmaceutical industry, Safety

NEW HAVEN, Conn., Oct. 13, 2023 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for difficult to treat patients with chronic cough in idiopathic pulmonary fibrosis (IPF), other chronic cough indications and prurigo nodularis, today announced the 52-week results from its phase 2b/3 PRISM open-label extension (OLE) study of Haduvio for the treatment of prurigo nodularis. The data was presented by Professor Elke Weisshaar on October 13th at the European Academy of Dermatology & Venereology (EADV) Congress 2023 in Berlin, Germany. The slides from the presentation will be available for 30 days on the Company's website.  

Key Points: 
  • The slides from the presentation will be available for 30 days on the Company's website .
  • "The long-term data also supports the continued effectiveness of Haduvio in reducing itch over 52 weeks for the participants who remained in the study.
  • We are preparing for an end of phase 2 meeting with the FDA to discuss next steps in development for this program."
  • The phase 2b/3 PRISM (Pruritus Relief through Itch-Scratch Modulation) trial was a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of nalbuphine ER in prurigo nodularis.

Trevi Therapeutics Announces Notice of Allowance for U.S. Patent Application Covering Use of Haduvio™ (nalbuphine ER) for the Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis

Retrieved on: 
Wednesday, March 8, 2023
Orange Book, Chronic cough, Nalbuphine, Patent, Trevi, IPF, United States Patent and Trademark Office, Idiopathic pulmonary fibrosis, Therapy, Pharmaceutical industry, HAVEN

(Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in adults with idiopathic pulmonary fibrosis (IPF) and other chronic cough indications, today announced that on March 7, 2023, the United States Patent and Trademark Office ("USPTO") issued a notice of allowance for nalbuphine ER's method of treatment of chronic cough in IPF.

Key Points: 
  • (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in adults with idiopathic pulmonary fibrosis (IPF) and other chronic cough indications, today announced that on March 7, 2023, the United States Patent and Trademark Office ("USPTO") issued a notice of allowance for nalbuphine ER's method of treatment of chronic cough in IPF.
  • Trevi expects the resulting patent will be Orange Book-listable with an anticipated expiration in 2039.
  • Trevi intends to continue to prosecute additional patent applications to further enhance its existing patent estate protecting nalbuphine ER across multiple chronic cough conditions as additional clinical data is generated.
  • "We are pleased with this allowance of claims to further secure IP protection for Haduvio through 2039 for the treatment of chronic cough in IPF," said Jennifer Good, President and CEO of Trevi Therapeutics.

Trevi Therapeutics, Inc. Discusses Progress and 2022 Success of Clinical Studies for Its Investigational Oral Therapy Haduvio(TM) with The Stock Day Podcast

Retrieved on: 
Wednesday, January 25, 2023
Disease, Therapy, Interview, Safety, History, Prurigo nodularis, Nalbuphine, Patient, Chronic cough, Mortality, CMO, IPF, Pharmaceutical industry

President and CEO of the Company, Jennifer Good, joined Stock Day host Everett Jolly.

Key Points: 
  • President and CEO of the Company, Jennifer Good, joined Stock Day host Everett Jolly.
  • "Our path forward here is through severe chronic cough, which is also linked to some tough diseases."
  • Jolly then asked for an update on the Company's Phase 2 CANAL trial of its investigational oral therapy Haduvio™ in chronic cough in IPF.
  • She also encouraged listeners and shareholders to keep up-to-date on the Company's upcoming announcements and current projects as they continue to progress clinically.

Trevi Therapeutics to Present and Participate in Upcoming Conferences in San Francisco During the 41st Annual J.P. Morgan Health Care Conference

Retrieved on: 
Monday, December 19, 2022
United, Prurigo nodularis, Route of administration, Nalbuphine, Interstitial lung disease, Trevi, Partnership, Itch, Risk, Conference, Chronic cough, Vicki Belo, Safety, DEA, IPF, Therapy, Idiopathic pulmonary fibrosis, Cough, Pharmaceutical industry

NEW HAVEN, Conn., Dec. 19, 2022  /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 adults with idiopathic pulmonary fibrosis (IPF), other chronic cough indications, and for the treatment of prurigo nodularis, today announced senior leadership will attend and present at the following investor and partnership conferences in January. These events will take place in San Francisco during the week of the annual J.P. Morgan Health Care Conference.

Key Points: 
  • These events will take place in San Francisco during the week of the annual J.P. Morgan Health Care Conference.
  • Biotech Showcase 2023 (January 9-11, 2023)
    For more information or to register, please click here .
  • Based on this positive data, Trevi plans to focus future clinical development on chronic cough conditions, including IPF, refractory chronic cough, and interstitial lung diseases (ILDs).
  • The ĸ- and µ-opioid receptors are centrally and peripherally active and known to be critical mediators of cough and itch.

Trevi Therapeutics Appoints Pharma Industry Veteran as Chief Medical Officer

Retrieved on: 
Monday, November 14, 2022
GlaxoSmithKline, Idiopathic pulmonary fibrosis, Wilson Therapeutics, IPF, U.S. Securities and Exchange Commission, Security (finance), Nalbuphine, MRCP, University of Edinburgh Medical School, Vicki Belo, Knowledge, Trevi, Royal college, Safety, United Kingdom, University, Interstitial lung disease, Prurigo nodularis, Company, Nasdaq, Therapy, Membership of the Royal Colleges of Physicians of the United Kingdom, Research, Private Securities Litigation Reform Act, Patient, COVID-19, CEO, Risk, Clinical trial, DEA, Chronic cough, Itch, Route of administration, CMO, Drug development, Disease, Cough, Pharmaceutical industry, Medicine, MD, HAVEN, Pfizer

NEW HAVEN, Conn., Nov. 14, 2022 /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 adults with idiopathic pulmonary fibrosis (IPF) and other chronic cough indications, and for the treatment of prurigo nodularis, today announced the appointment of David Clark, MD, MRCP, as Chief Medical Officer (CMO). Dr. Clark will join Trevi's executive team and be responsible for the strategy and execution of Haduvio's clinical programs.

Key Points: 
  • Most recently, Dr. Clark served as Chief Medical Officer at Allena Pharmaceuticals, leading the Company's clinical development, regulatory and medical affairs teams.
  • Prior to that, he served as Chief Medical Officer for various companies, including Aldeyra Therapeutics, Wilson Therapeutics, and NormOxys.
  • As Chief Medical Officer, Dr. Clark has strategized and supported teams from clinical translation through Phase 3.
  • Dr. Thomas Sciascia, MD, the co-founder of Trevi Therapeutics, previously served as Trevi's Chief Medical Officer and will be transitioning to Chief Science Officer.

Trevi Therapeutics to Participate at the Stifel 2022 Healthcare Conference

Retrieved on: 
Tuesday, November 8, 2022
News, Idiopathic pulmonary fibrosis, DEA, Company, Vicki Belo, Trevi, Nalbuphine, Route of administration, IPF, Interstitial lung disease, Conference, Itch, Nasdaq, Chronic cough, Cough, EDT, Therapy, Risk, Safety, Pharmaceutical industry

NEW HAVEN, Conn., Nov. 8, 2022 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of serious chronic cough conditions, today announced that Jennifer Good, President and Chief Executive Officer, and Lisa Delfini, Chief Financial Officer, will participate in a fireside chat at the Stifel 2022 Healthcare Conference on Wednesday, November 16, 2022, at 3:35 p.m. ET.

Key Points: 
  • A live audio webcast of the fireside chat will be accessible from the 'Investors & News' section on the Company's website at www.TreviTherapeutics.com .
  • An archived replay of the audio webcast will also be available on the Company's website following the event.
  • Trevi Therapeutics, Inc.is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational oral therapy Haduvio (nalbuphine ER) for the treatment of serious chronic cough conditions.
  • Based on this positive data, Trevi plans to focus future clinical development on chronic cough conditions, including IPF, refractory chronic cough, and interstitial lung diseases (ILDs).

Trevi Therapeutics to Report Q3 2022 Financial Results and Provide a Corporate Update on November 10, 2022

Retrieved on: 
Thursday, November 3, 2022
Company, Nalbuphine, Chronic cough, EDT, Vicki Belo, Cough, Idiopathic pulmonary fibrosis, Safety, Webcast, Route of administration, Therapy, Trevi, IPF, Nasdaq, Review, Conference call, Risk, Itch, DEA, Interstitial lung disease, News, Pharmaceutical industry, Conference

NEW HAVEN, Conn., Nov. 3, 2022 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of serious chronic cough conditions, today announced that management will host a conference call and live audio webcast on Thursday, November 10, 2022, at 4:30 p.m. ET, to provide a corporate update and review the Company's financial results for the third quarter ended September 30, 2022.

Key Points: 
  • ET, to provide a corporate update and review the Company's financial results for the third quarter endedSeptember 30, 2022.
  • To participate in the live conference call by phone, please dial (888) 317 6003 (domestic) or (412) 317 6061 (international) and provide access code 4950734.
  • A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.TreviTherapeutics.com .
  • An archived replay of the webcast will also be available for 30 days on the Company's website following the event.

Trevi Therapeutics to Present Final Data from Phase 2 Trial of Oral Nalbuphine Extended Release for Chronic Cough in IPF at BTS' Winter Meeting

Retrieved on: 
Thursday, October 27, 2022
Idiopathic pulmonary fibrosis, IPF, Winter Meeting, British Thoracic Society, Chronic cough, Therapy, Patient, Quality of life, MD, Caregiver, Fatigue, National Heart, Lung, and Blood Institute, Nasdaq, Nalbuphine, Cough, Medical school, BTS, Pharmaceutical industry, HAVEN

NEW HAVEN, Conn., Oct. 27, 2022 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of serious chronic cough conditions, today announced data from the full set of subjects from CANAL, a phase 2 trial in idiopathic pulmonary fibrosis (IPF) chronic cough, will be presented as an oral presentation at the upcoming British Thoracic Society's (BTS) Winter Meeting 2022 taking place in London, United Kingdom.

Key Points: 
  • The CANAL (Cough And NALbuphine) trial was a Phase 2 double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover efficacy and safety study of nalbuphine ER for chronic cough in IPF.
  • There are no approved therapies for the treatment of chronic cough in IPF and the cough often isn't affected by antitussive therapy.
  • The Company has successfully completed a Phase 2 trial of Haduvio for the treatment of chronic cough in adults with idiopathic pulmonary fibrosis (IPF).
  • Based on this positive data, Trevi plans to focus future clinical development on chronic cough conditions, including IPF, refractory chronic cough, and interstitial lung diseases (ILDs).

Trevi Therapeutics to Present at H.C. Wainwright 24th Annual Global Investment Conference

Retrieved on: 
Wednesday, September 7, 2022
Safety, Movement disorders, Therapy, Chronic cough, Nalbuphine, Route of administration, Itch, EDT, DEA, Fast Track, Conference, Nasdaq, FDA, Cough, IPF, Risk, Prurigo nodularis, Idiopathic pulmonary fibrosis, Patient, Pharmaceutical industry

NEW HAVEN, Conn., Sept. 7, 2022 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis (IPF), today announced that Jennifer Good, President and Chief Executive Officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12, 2022, at 10:30 a.m. ET. Ms. Good, along with Lisa Delfini, Chief Financial Officer, will also participate in investor meetings with attendees.

Key Points: 
  • Ms. Good, along with Lisa Delfini, Chief Financial Officer, will also participate in investor meetings with attendees.
  • For more information about the H.C. Wainwright 24th Annual Global Investment Conference or to register in-person or virtual please visit: https://hcwevents.com/annualconference/
    Trevi Therapeutics, Inc.is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio for the treatment of prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis.
  • These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.
  • Founded in 2011,Trevi Therapeuticsis headquartered inNew Haven, CT.
    Haduvio, an investigational therapy, is an oral extended-release (ER) formulation of nalbuphine.

Trevi Therapeutics to Host Virtual R&D Day on September 19, 2022

Retrieved on: 
Tuesday, August 30, 2022
Neuroinflammation, Security (finance), COVID-19, Division, Safety, Interest, Sensation, Movement disorders, Therapy, Chronic cough, Route of administration, Itch, Interim, Critical Care Medicine (journal), MTR, U.S. Securities and Exchange Commission, Montefiore Medical Center, DEA, Fast Track, Nasdaq, Company, FDA, PRISM, Cough, IPF, Risk, Webcast, Clinical trial, Trevi, Private Securities Litigation Reform Act, Prurigo nodularis, Q&A, Prurigo, Idiopathic pulmonary fibrosis, Patient, Pharmaceutical industry, Medicine, MD, Nalbuphine

NEW HAVEN, Conn., Aug. 30, 2022 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis (IPF), today announced that it will host a virtual R&D Day on Monday, September 19, 2022, from 10:00 AM to 12:30 PM Eastern Time.

Key Points: 
  • They will be joined by Trevi's leadership team who will provide an update on the Company's development plans for Haduvio, followed by a live Q&A session.
  • A live webcast, including audio, video, and presentation slides, will be accessible on ir.trevitherapeutics.com at the time of the meeting.
  • 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.