FDA Formally Sends Merck "Back To Drawing Boards", On Its Next Gen Cough Med -- GSK May Benefit...

We earlier mentioned that this would be the likely outcome. And we said, and still believe -- this should not change Merck's NYSE price, in any way -- when the denial came.

And then we predicted that GSK could benefit from going to school -- on where Merck missed the mark, three weeks ago. Now. . . FDA has tonight formally issued a denial -- what are now politely called "complete response letters" -- to Merck. No surprise -- and immaterial overall:

. . .[Merck] announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the safety of gefapixant. Merck is reviewing the FDA’s feedback to determine next steps.

Chronic cough is defined as a cough lasting longer than 8 weeks. In adults with RCC, the cough persists despite appropriate treatment of underlying conditions such as asthma or gastroesophageal reflux disease, and UCC is a cough where the underlying cause cannot be identified despite a thorough evaluation. . . .

Now you know. Onward -- to a second graders' pageant -- for the '23 holidays! Woot!

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