‘A done deal’: FDA advisory committee votes unanimously against efficacy data for OTC nasal decongestant

Mem­bers of an FDA ad­vi­so­ry com­mit­tee on Tues­day vot­ed unan­i­mous­ly against the ef­fi­ca­cy of an over-the-counter nasal de­con­ges­tant that’s been on the US mar­ket for more than 75 years.

The FDA called up­on the Non­pre­scrip­tion Drugs Ad­vi­so­ry Com­mit­tee to weigh in on new da­ta on oral phenyle­phrine, an in­gre­di­ent in pop­u­lar prod­ucts such as Mucinex and Be­nadryl. Mem­bers vot­ed 16-0 that da­ta sug­gest the med­ica­tion is not ef­fec­tive at the cur­rent­ly rec­om­mend­ed 10 mg dose for nasal de­con­ges­tion, and a ma­jor­i­ty agreed that they aren’t like­ly to be swayed by fur­ther re­search.

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