FDA rais­es con­cerns over ef­fi­ca­cy of Mer­ck­'s po­ten­tial chron­ic cough drug ahead of ad­comm

The FDA’s Pul­monary-Al­ler­gy Drugs Ad­vi­so­ry Com­mit­tee will meet Fri­day to dis­cuss Mer­ck’s ap­pli­ca­tion for its chron­ic cough oral drug gefapix­ant, with the agency say­ing the key is­sue is un­cer­tain­ty about its ben­e­fit.

In brief­ing doc­u­ments re­leased Wednes­day, the FDA said there was a “small” re­duc­tion in cough­ing fre­quen­cy com­pared to a high re­sponse in the place­bo group and “lim­it­ed” sup­port­ive ev­i­dence from pa­tient-re­port­ed out­comes. Side ef­fects are al­so a part of the con­cern, with the agency not­ing a high rate of taste dis­tur­bance.

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