FDA hands CRL to Merck’s chronic cough drug over efficacy questions

The FDA hand­ed a com­plete re­sponse let­ter (CRL) on Wednes­day to Mer­ck for its cough drug gefapix­ant fol­low­ing an ad­comm that vot­ed against the drug ap­pli­ca­tion.

In the CRL, the agency said that Mer­ck’s ap­pli­ca­tion “did not meet sub­stan­tial ev­i­dence of ef­fec­tive­ness” for treat­ing re­frac­to­ry chron­ic cough or un­ex­plained chron­ic cough in adults. The CRL had noth­ing to do with the safe­ty of gefapix­ant, the re­lease states.

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