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Trevi Therapeutics to receive US patent covering use of nalbuphine ER's method of treatment of chronic cough in IPF

New Haven, Connecticut
Thursday, March 9, 2023, 14:00 Hrs  [IST]

Trevi Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced that 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. "We expect that this allowed patent application when issued will provide important protection along with the already issued formulation patents and other patent applications that we are prosecuting."

IPF is a serious, end-of-life disease. Chronic cough is one of the most common symptoms of IPF and has a significant impact on quality of life in these patients. There are estimated to be 140,000 IPF patients in the US and more than 1 million patients ex-US, where up to 85% of these patients experience chronic cough. There are no approved therapies for the treatment of chronic cough in IPF and the cough often isn't affected by antitussive therapy. Patients with chronic cough in IPF can cough up to 1,500 times per day, leading to increased feelings of fear and stress as it causes shortness of breath. Coughing spells or episodes lead to significant fatigue, an urge to breathe, low levels of oxygen in blood, and some patients also experience loss of bladder control. The social impact of chronic cough in IPF is increased because of limited exercise ability, reduced walking distance, and the need to use additional oxygen. Chronic cough in IPF may be an early clinical marker of disease activity that could potentially help to identify patients at high risk of progression and predict time to death or lung transplant. In addition, chronic cough in IPF may also contribute to enhanced activation of profibrotic mechanisms and disease worsening.

Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio, an investigational therapy in an oral extended-release formulation of nalbuphine, for the treatment of chronic cough in IPF and other chronic cough indications.


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