FDA declines to approve gefapixant for chronic cough a second time

The FDA has issued a complete response letter declining to approve a new drug application for gefapixant as a treatment for adults with refractory or unexplained chronic cough, according to a press release from Merck.

This is the second time the FDA has declined to approve gefapixant (Merck), an investigational, non-narcotic orally administered selective P2X3 receptor antagonist.

Notably, this decision follows the recommendation given by the FDA’s Pulmonary-Allergy Drug Advisory Committee in November, in which a majority of the panelists voted against approving gefapixant.

According to the release, the FDA’s letter was not related to the safety of the drug. Merck stated that they will figure out next steps after reviewing the letter.

At the moment, there are no FDA-approved therapies for this condition.

“We thank our clinical trial participants and investigators for their important contributions that add to the body of knowledge related to chronic cough and help to raise awareness about the significant unmet medical need and the impact of [refractory chronic cough] and [unexplained chronic cough] on patients,” Joerg Koglin, MD, PhD, senior vice president of global clinical development at Merck Research Laboratories, said in the release. “Acknowledging the absence of any approved treatments for refractory or unexplained chronic cough, we are disappointed in the FDA’s response to our application for gefapixant.”