Trevi Therapeutics: Haduvio Trial Results on March 10
Trevi Therapeutics will host a conference call and webcast on March 10th to share topline results from the Phase 2a RIVER Trial of haduvio in patients with refractory chronic cough.
NEW HAVEN, conn., March 9, 2025 – Trevi Therapeutics, inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company, is set to announce key findings regarding its investigational therapy, Haduvio™ (oral nalbuphine ER). This treatment is being developed for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).The announcement will be made during a conference call and live webcast tomorrow, Monday, March 10th, 2025, at 8:30 am.
The focus of the event is to share topline results from the Phase 2a RIVER trial of Haduvio in patients with refractory chronic cough. This is a notable step in the ongoing research and development of treatments for this debilitating condition.
Conference Call Details
Table of Contents
- Conference Call Details
- Understanding Refractory Chronic Cough (RCC)
- About Trevi Therapeutics, Inc.
- Contacts
- trevi Therapeutics’ Haduvio™ (oral nalbuphine ER) for Chronic Cough: Q&A
- What is the latest news from Trevi Therapeutics regarding Haduvio™?
- What is Haduvio™ and what conditions is it being developed for?
- what is Refractory Chronic Cough (RCC)?
- How prevalent is Refractory Chronic Cough (RCC)?
- What are the impacts and burdens of Refractory chronic Cough (RCC)?
- How dose Haduvio™ work?
- What is the meaning of chronic cough in Idiopathic Pulmonary Fibrosis (IPF) patients?
- What are the potential consequences of chronic cough in IPF patients?
- Are there any approved therapies for chronic cough in IPF patients?
- What is the Phase 2a RIVER trial?
- How can I access the Trevi Therapeutics conference call and webcast?
- What are Kappa Agonists and Mu Antagonists (KAMA)?
- Key Takeaways: Haduvio™ for Chronic Cough
- Where can I find more facts about Trevi Therapeutics?
- Who are the media and investor contacts for Trevi Therapeutics?
The company will host a conference call and webcast to review the topline results. the live webcast, including audio and presentation slides, will be accessible at the time of the meeting. 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.
Understanding Refractory Chronic Cough (RCC)
Refractory chronic cough is a condition with no approved therapies in the U.S. It is indeed defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition
, such as asthma or gastroesophageal reflux disease. This also includes unexplained chronic cough. RCC affects approximately 2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves.
The impact of RCC is substantial. It is indeed described as 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 dedicated to developing innovative therapies. Their focus is on 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. Ther 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 Trevi Therapeutics’ website and follow them on X (formerly Twitter) and LinkedIn.
Contacts
Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
carlsonj@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
trevi Therapeutics’ Haduvio™ (oral nalbuphine ER) for Chronic Cough: Q&A
What is the latest news from Trevi Therapeutics regarding Haduvio™?
Trevi Therapeutics, Inc. (nasdaq: TRVI) will announce topline results from its Phase 2a RIVER trial of Haduvio™ (oral nalbuphine ER) in patients with refractory chronic cough (RCC) on March 10th, 2025. The announcement will be made during a conference call and live webcast at 8:30 am.
What is Haduvio™ and what conditions is it being developed for?
haduvio™ (oral nalbuphine ER) is an investigational therapy being developed by Trevi Therapeutics for the treatment of chronic cough in patients with:
Idiopathic pulmonary fibrosis (IPF)
Refractory chronic cough (RCC)
what is Refractory Chronic Cough (RCC)?
Refractory chronic cough (RCC) is defined as a persistent cough lasting more than 8 weeks despite treatment for underlying conditions like asthma or gastroesophageal reflux disease.It also includes unexplained chronic cough. There are currently no approved therapies for RCC in the U.S.
How prevalent is Refractory Chronic Cough (RCC)?
RCC affects approximately 2-3 million patients in the U.S. It is caused by cough reflex hypersensitivity in both the central and peripheral nerves.
What are the impacts and burdens of Refractory chronic Cough (RCC)?
RCC is a highly debilitating disease accompanied by a wide range of complications, including:
Urinary incontinence (in females)
Sleep disruption
Social embarrassment
These complications can cause significant social and economic burdens for patients and those around them.
How dose Haduvio™ work?
Haduvio™ acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA). Kappa and mu receptors are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine, the active ingredient, is not currently scheduled by the U.S.drug Enforcement Agency.
What is the meaning of chronic cough in Idiopathic Pulmonary Fibrosis (IPF) patients?
Chronic cough is highly prevalent in IPF patients, impacting up to 85% of the IPF population. There are approximately 140,000 IPF patients in the U.S., with patients coughing up to 1,500 times a day.
What are the potential consequences of chronic cough in IPF patients?
The consistent cough and associated damage may lead to:
Worsening of disease
Higher risk of progression
death
Need for lung transplant
Decline in social, physical, and psychological quality of life
Are there any approved therapies for chronic cough in IPF patients?
No, there are no approved therapies for the treatment of chronic cough in patients with IPF. Current off-label treatment options provide minimal benefit to patients.
What is the Phase 2a RIVER trial?
The Phase 2a RIVER trial is a study of Haduvio™ in patients with refractory chronic cough. Trevi Therapeutics will announce the topline results of this trial on March 10th, 2025.
How can I access the Trevi Therapeutics conference call and webcast?
Live Webcast: Accessible at the time of the meeting via trevi Therapeutics’ website. The webcast will include audio and presentation slides.
conference Call by Phone:
Domestic: (877) 870 4263
International: (412) 317 0790
Ask to join the Trevi Therapeutics call. no access code is necessary.
Archived Replay: An archived replay of the webcast will be available for 30 days on the Company’s website following the event.
What are Kappa Agonists and Mu Antagonists (KAMA)?
Kappa agonists and mu antagonists (KAMA) are types of opioid receptor modulators. In the context of Haduvio™, these mechanisms are believed to play a role in controlling cough hypersensitivity:
Kappa Agonist: Stimulates the kappa opioid receptors.
Mu Antagonist: blocks the mu opioid receptors.
This dual action is central to how Haduvio™ is designed to alleviate chronic cough, especially in conditions like IPF and RCC.
Key Takeaways: Haduvio™ for Chronic Cough
| Feature | Details |
| ———————— | ———————————————————————————————————————————————————————————————————————————————————————————————– |
| Drug | Haduvio™ (oral nalbuphine ER) – Investigational Therapy |
| Developer | Trevi Therapeutics, Inc. |
| Target Conditions | Chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF) and Refractory Chronic Cough (RCC) |
| Mechanism of Action | Kappa Agonist and Mu Antagonist (KAMA) – acts on the cough reflex arc centrally and peripherally |
| clinical Trial | phase 2a RIVER Trial (Refractory Chronic Cough) | |
| US Prevalence (RCC) | Approximately 2-3 million patients |
| IPF Impact | Affects up to 85% of IPF patients, leading to coughing up to 1,500 times per day and potential disease progression |
| Conference Call Date | March 10th, 2025, 8:30 AM |
Where can I find more facts about Trevi Therapeutics?
For more information, visit the Trevi Therapeutics’ website and follow them on X (formerly Twitter) and LinkedIn.
Who are the media and investor contacts for Trevi Therapeutics?
investor Contact
Jonathan Carlson
Trevi Therapeutics,Inc.
(203) 654 3286
carlsonj@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
* rscampoli@marketcompr.com