Richard Lowenthal, ARS Pharmaceuticals president and co-founder

FDA ad­comm votes in fa­vor of ARS Phar­ma­ceu­ti­cal­s' EpiPen al­ter­na­tive

An ad­vi­so­ry com­mit­tee of out­side ex­perts to the FDA to­day vot­ed 16-6 in fa­vor of ARS Phar­ma­ceu­ti­cals’ EpiPen al­ter­na­tive for adults (and 16-5 for chil­dren who weigh about 66 pounds or more) which, if ap­proved, would be the first ep­i­neph­rine nasal spray on the US mar­ket.

The vote was a sur­prise as mul­ti­ple ad­comm mem­bers ques­tioned the nasal spray’s ben­e­fit-risk pro­file, and called for some clin­i­cal da­ta on the nasal spray to be pro­duced be­fore it can be ap­proved, al­though some ques­tioned whether a small­er clin­i­cal study might be enough.

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