06:00 PM EDT, 03/14/2024 (MT Newswires) -- Aquestive Therapeutics ( AQST ) said Thursday its sublingual film epinephrine experimental drug Anaphylm showed exposure levels comparable to autoinjectors and was quicker to reach maximum concentration in a phase 3 study.

The two-part study focused on pharmacokinetics, the way a drug is absorbed, and pharmacodynamics, the way it affects the body, of single and multiple doses of Anaphylm compared to epinephrine intra-muscular injection and autoinjectors, according to the company.

Anaphylm met all predefined primary and secondary pharmacokinetic endpoints of the study and was well tolerated with no serious adverse events reported, the company said.

Aquestive said the US Food and Drug Administration has recommended an additional study of Anaphylm to evaluate the impact of potential mouth conditions and it will execute the study in H2.

The company expects to file a new drug application with the FDA before the end of the year.

Aquestive shares were up 3% in recent after-hours trading.

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