Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, developed for the treatment for adults with refractory or unexplained chronic cough.

The CHMP’s recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU) and a final decision is expected later this year.

“Today’s positive CHMP opinion is the next step for gefapixant to become the first treatment approved in the European Union for adults with refractory or unexplained chronic cough,” said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. “Refractory or unexplained chronic cough as a condition with often disruptive, uncontrolled coughing associated with major physical, social and emotional consequences represent a large unmet clinical need.”

The CHMP’s positive opinion is based on results from the COUGH-1 and COUGH-2 clinical trials, which are the first companion Phase 3 studies ever completed in patients with refractory or unexplained chronic cough, a cough that persists despite appropriate treatment of underlying conditions or for which the underlying cause cannot be identified despite a thorough evaluation. Both studies met the primary endpoint, demonstrating a statistically significant reduction in 24-hour cough frequency in adults treated with gefapixant 45 mg twice daily versus placebo at 12 weeks (COUGH-1) and 24 weeks (COUGH-2).