Merck’s Gefapixant: FDA Questions Whether Small Reduction In Chronic Cough Is Clinically Meaningful

Gefapixant 45 mg had a 15% to 17% relative reduction in 24-hour cough frequency compared to placebo from baseline to week 24 or week 12. Advisory committee to vote on whether this decrease along with results from patient-reported outcomes demonstrate a clinically meaningful benefit.

Cough
FDA panel to consider clinical data on Merck's drug for treatment of chronic cough • Source: Shutterstock

Merck & Co., Inc.’s gefapixant may have difficulty winning the support of an advisory committee given its limited effect in reducing chronic cough, but the lack of any approved treatment for the condition may give it an edge.

The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee is to consider the evidence of effectiveness for gefapixant, an...

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