Trevi Therapeutics, Inc.

The company is a clinical-stage biopharmaceutical company focused on developing and commercializing Haduvio (oral nalbuphine ER). Haduvio is an investigational therapy for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). This therapy is an oral extended-release formulation of nalbuphine. Haduvio works on the cough reflex by acting centrally and peripherally as a kappa receptor agonist and a mu receptor antagonist ("KAMA"), targeting opioid receptors involved in controlling chronic cough. Kappa- and mu-opioid receptors are known to be critical mediators of cough. Nalbuphine, in its injectable form, has been approved and marketed for pain indications for decades in the U.S. and Europe. Haduvio's mechanism of action also reduces the risk of abuse associated with mu-opioid agonists because it blocks the mu-opioid receptor. Parenteral nalbuphine is not classified as a controlled substance by the U.S. Drug Enforcement Agency and in most of Europe. The company is developing Haduvio for IPF-related chronic cough, a progressive fibrosing interstitial lung disease with high mortality rates. The median survival after an IPF diagnosis is 3 to 5 years. There are approximately 150,000 U.S. patients with IPF, and two-thirds of these patients experience uncontrolled chronic cough. Patients may cough up to 1,500 times per day. There are currently no FDA-approved therapies for IPF-related chronic cough.