Merck’s Chronic Cough Med Gefapixant Receives A Red Flag From the FDA, Requests For More Data
On 24th January 2022, Merck & Co. announced FDA rejection for its New Drug Application (NDA) of Gefapixant (experimental drug) for unexplained or chronic cough. FDA asked for additional information on the drug, related only to the effectiveness and not safety. The drug is an oral selective, non-narcotic, P2X3 receptor antagonist. With this disapproval in hand, there are currently no FDA-approved drugs for the treatment of unexplained/chronic/refractory cough. Unexplained chronic cough is a cough lasting at least 8 weeks with no etiology identified despite a thorough in...