Trevi Therapeutics Announces Completion of End-of-Phase 2 Meeting with the FDA, Gaining Alignment for Its Development Program for Idiopathic Pulmonary Fibrosis-Related Chronic Cough
MWN-AI** Summary
Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company, has successfully completed its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its investigational therapy, Haduvio™ (oral nalbuphine extended-release), designed to treat chronic cough in patients with idiopathic pulmonary fibrosis (IPF). During the meeting, Trevi received alignment on its proposed Phase 3 clinical development program, which will include two pivotal trials aimed at assessing the safety and efficacy of Haduvio for IPF-related chronic cough.
The first Phase 3 trial is set to initiate in the second quarter of 2026, followed by the second trial expected to commence in the second half of the same year. Both trials will be randomized, double-blind, placebo-controlled multicenter studies. The primary efficacy endpoint will evaluate the change from baseline in 24-hour cough frequency over specified periods, utilizing an objective cough monitor.
Trevi's Haduvio is distinct in targeting chronic cough, a significant concern for the approximately 150,000 patients with IPF in the U.S., with around two-thirds experiencing uncontrolled cough, severely impacting their quality of life. The company is optimistic about addressing this unmet need, especially in a therapeutic landscape currently void of FDA-approved treatments for IPF-related chronic cough.
James Cassella, PhD, Chief Development Officer, emphasized the constructive dialogue with the FDA and outlined plans for the remaining Phase 1 studies essential for supporting the New Drug Application (NDA). The therapeutic potential of Haduvio, acting as a kappa agonist and mu antagonist, offers hope to IPF patients, indicating Trevi's commitment to advancing its development program effectively.
MWN-AI** Analysis
Trevi Therapeutics, Inc. (Nasdaq: TRVI) recently announced a significant milestone with the completion of its End-of-Phase 2 meeting with the FDA regarding Haduvio™ (nalbuphine ER) for treating idiopathic pulmonary fibrosis (IPF)-related chronic cough. This announcement signals a pivotal step forward for both the company and its investors, as the efficacy of Haduvio could address a critical unmet need in a market with approximately 150,000 IPF patients in the U.S.
The alignment with the FDA on the Phase 3 clinical trial plan positions Trevi favorably in the biopharmaceutical landscape. With two pivotal trials set to begin between the second quarter and the second half of 2026, Trevi is strategically preparing to generate data that could be compelling for the New Drug Application (NDA) submission. The company's focus on establishing safety and efficacy will be critical, particularly given the history of limited treatments available for chronic cough associated with IPF.
For investors, this development may suggest potential upside as Trevi continues to pursue necessary clinical milestones. Haduvio is unique as the first investigational therapy demonstrating statistically significant reductions in cough frequency in clinical trials targeting both IPF-related and refractory chronic cough patients. If successful, Trevi could capture a significant share of the market, especially as it continues to navigate its trial processes diligently.
However, potential investors should remain cognizant of the inherent risks associated with clinical drug development, including regulatory uncertainties and the possibility that favorable trial results may not guarantee eventual FDA approval. Given these factors, prospective investors should consider their risk tolerance and stay informed about further developments in Trevi's clinical programs and the broader market landscape for IPF therapies. Engaging in a measured approach—balancing the prospects of Haduvio with the associated risks—will be crucial as Trevi progresses through its development phases.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
The Company will conduct two Phase 3 clinical trials of nalbuphine ER for the treatment of patients with IPF-related chronic cough
First pivotal trial is on track to initiate in the second quarter of 2026, with the second pivotal trial expected to initiate in the second half of 2026
NEW HAVEN, Conn., March 09, 2026 (GLOBE NEWSWIRE) -- 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 the results of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). At the meeting, the Company gained overall alignment on the plan for the remaining development program. The Company plans to conduct two pivotal Phase 3 clinical trials and obtained agreement on the remaining Phase 1 clinical studies that the Company expects to conduct to support the New Drug Application (NDA) submission. The Company plans to conduct the Phase 3 trials in parallel with each other and is on track to initiate the first Phase 3 trial in the second quarter of 2026 and the second Phase 3 trial in the second half of 2026.
“We very much appreciate the FDA’s careful review of our IPF-related chronic cough program to date and the highly collaborative discussions we had during the meeting,” said James Cassella, PhD, Chief Development Officer of Trevi Therapeutics. “We clarified the path forward for our Phase 3 program and received useful guidance on the remaining Phase 1 studies to be conducted. We are well positioned to initiate pivotal parallel Phase 3 trials beginning in the second quarter of 2026 and to execute on the remaining development program.”
Jennifer Good, President and CEO of Trevi Therapeutics, added, “The End-of-Phase 2 meeting was an important milestone for the Company, and we are grateful for the guidance from the FDA. With no FDA-approved therapies for IPF-related chronic cough, it remains highly burdensome for patients living with IPF and is a condition which has historically had limited options. Our team is focused on advancing Haduvio for these patients and potentially addressing this urgent unmet need.”
The Phase 3 trials will both be randomized, double-blind, placebo-controlled, multicenter, global trials evaluating the safety and efficacy of nalbuphine ER tablets, with 54 mg twice-a-day (BID) dosing, for the treatment of patients with IPF-related chronic cough. Patients enrolled in the trials will be randomized 2:1 to either nalbuphine ER or placebo. The first of the two Phase 3 trials is planned to enroll approximately 300 patients with IPF-related chronic cough and have 52 weeks of fixed dosing, with the primary endpoint at 24 weeks of fixed dosing. The other Phase 3 trial is planned to enroll approximately 130 patients with IPF-related chronic cough and have 12 weeks of fixed dosing. The primary efficacy endpoint for both trials will be the relative change from Baseline in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for nalbuphine ER compared with placebo. These trial designs are subject to final review of the protocols by the FDA.
About Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough
Chronic cough in patients with IPF is a condition with high unmet need and no FDA-approved therapies. There are ~150,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. 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 a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life.
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 clinical trials across both 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.
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 www.TreviTherapeutics.com 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, statements regarding FDA guidance, 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, 2025 filed with the Securities and Exchange Commission and in subsequent filings made by the Company 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
IR@trevitx.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
FAQ**
How does Trevi Therapeutics Inc. TRVI plan to fund the upcoming Phase 3 clinical trials for nalbuphine ER, and what are the financial implications if the trials do not meet their endpoints?
What specific criteria will Trevi Therapeutics Inc. TRVI use to evaluate the success of the two Phase 3 trials, particularly regarding the primary endpoint of 24-hour cough frequency?
Can Trevi Therapeutics Inc. TRVI outline the potential market size and competitive landscape for Haduvio™, given the current lack of FDA-approved therapies for IPF-related chronic cough?
What feedback or guidelines did Trevi Therapeutics Inc. TRVI receive from the FDA during the End-of-Phase 2 meeting that could impact the design and execution of the Phase 3 trials?
**MWN-AI FAQ is based on asking OpenAI questions about Trevi Therapeutics Inc. (NASDAQ: TRVI).
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