FX.co ★ Aquestive Therapeutics Says FDA Provides Positive Feedback On NDA Submission For Anaphylm

Aquestive Therapeutics, Inc. (AQST), a pharmaceutical company, announced on Monday the positive feedback it has received from the U.S. Food and Drug Administration (FDA) regarding its anticipated New Drug Application (NDA) submission for Anaphylm, an epinephrine sublingual film.

Anaphylm has the potential to become the first orally administered epinephrine treatment for severe allergic reactions, including anaphylaxis, pending FDA approval.

In its communication, the FDA concurred with the company's proposed NDA structure, content, safety evaluations, and pediatric trial plans, which are already underway in the U.S. and Canada.

Additionally, the FDA offered guidance on supplementary data to incorporate in the forthcoming NDA submission and reiterated the importance of pharmacokinetic sustainability for a single dose. The agency also requested minor alterations to the company's pediatric trial protocol.

Aquestive Therapeutics has integrated these requested changes into the final pediatric trial protocol, anticipating no significant delays in the trial's timeline.

The FDA also mentioned the possibility of an advisory committee meeting, given the novel administration route and supporting data for Anaphylm.