FDA Staff Question Efficacy Data of Merck's Chronic Cough Drug Gefapixant Ahead of Advisory Committee Review

Gelonghui November 16 | Staff from U.S. health regulatory agencies stated on Wednesday that data from Merck's chronic cough medication may not be sufficient to demonstrate the actual efficacy of this treatment. An expert advisory panel of the U.S. Food and Drug Administration (FDA) will hold a meeting on Friday to discuss the efficacy of Merck's drug gefapixant. The staff’s evaluation of the data submitted by Merck showed a slight reduction in cough frequency and side effects such as taste diminution among patients taking the drug. Compared with the placebo, the higher dose of the drug significantly reduced the average number of coughs per hour over 24 hours. Currently, there are no FDA-approved drugs for treating chronic cough in the United States. This drug by Merck has been approved for use in treating this condition in the EU and Japan, where it is marketed under the brand name Lyfnua.