Merck & Co rejected again for novel chronic cough drug

21 December 2023

For a second time, the US Food and Drug Administration has rejected a submission from Merck & Co (NYSE: MRK) for approval to market a chronic cough medication.

The agency issued a Complete Response Letter (CRL) in early 2022, demanding more data on efficacy in relation to the oral P2X3 receptor antagonist.

Now Merck has revealed another CRL has been issued, despite positive results from the COUGH-1 and COUGH-2 studies, both of which met their primary endpoints.

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