CHMP recommends Lyfnua as a treatment for refractory or unexplained chronic cough.- Merck Inc.,

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.

The CHMP’s positive opinion is based on results from the COUGH-1 and COUGH-2 clinical trials, which are the first companion Phase III 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).

The key benefit of the treatment with Lyfnua is the reduction in the frequency of coughs per 24 hours, as shown in two phase III, double-blind, placebo-controlled parallel assignment intervention studies evaluating the efficacy and safety of gefapixant in adults with refractory chronic cough or unexplained chronic cough. The most common side effects are a distortion, loss or reduction of the sense of taste.