Merck’s Chronic Cough Drug Fails to Secure FDA Approval for Second Time

For the second time in nearly two years, Merck has failed to secure regulatory approval for its chronic cough drug gefapixant.

In a Complete Response Letter issued Wednesday, the FDA said that Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness” for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The regulator did not point to safety issues related to the drug candidate.