FDA Accepts Merck’s NDA for Chronic Cough Medication

The FDA has accepted Merck’s new drug application (NDA) for gefapixant, an investigational, orally administered, selective P2X3 receptor antagonist for treating refractory or chronic cough in adult patients.

The agency’s target action date for gefapixant is Dec. 21. The agency will discuss the chronic cough drug candidate at an advisory committee meeting, but no date has yet been scheduled. Gefapixant would become the first drug approved specifically for the indications if the drug ends up earning the FDA’s blessing, Merck said.

Merck’s application was accepted based on results from two companion phase 3 studies, the first ones ever conducted in patients with refractory chronic cough (RCC), a cough that remains despite appropriate treatment, and unexplained chronic cough (UCC), a cough whose underlying cause cannot be pinpointed despite a thorough evaluation.