FDA Rejects MSD’s Gefapixant for Chronic Cough Treatment Over Efficacy Concerns

The US Food and Drug Administration (FDA) has declined to approve a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its P2X3 receptor antagonist, gefapixant, which was being considered as a treatment for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The rejection was due to insufficient evidence of the drug’s effectiveness, with MSD clarifying that the decision was not based on concerns regarding the safety profile of the oral drug candidate.- Fineline.com