Daniel Barber, Aquestive Therapeutics CEO

Aque­s­tive touts PhII da­ta — and speed — in po­ten­tial EpiPen re­place­ment can­di­date

A New Jer­sey biotech spe­cial­iz­ing in drug de­liv­ery via oral film is re­port­ing new Phase II da­ta, set­ting a count­down to have it be­fore the FDA by end of 2023.

Aque­s­tive Ther­a­peu­tics an­nounced new da­ta Tues­day for its can­di­date AQST-109, an oral film us­ing a pro­drug of ep­i­neph­rine to treat ana­phy­lac­tic shock from an al­ler­gic re­ac­tion.

Per the biotech, a read­out of the EPIPHAST II tri­al was to com­pare one dose of AQST-109 — ba­si­cal­ly a patch — to a dose of an EpiPen at 0.3 mg, and an in­tra­mus­cu­lar in­jec­tion of 0.3mg of ep­i­neph­rine that wasn’t EpiPen.

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