Pharmaceutical company Aquestive Therapeutics, Inc. (AQST) announced Monday the receipt of positive feedback from the U.S. Food and Drug Administration (FDA) prior to its planned NDA submission for Anaphylm (epinephrine) Sublingual Film.
Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis, if approved by the FDA.
In a written response, the FDA agreed with the Company's planned NDA content and format for the submission, planned safety evaluation, and planned pediatric trial, which has commenced at both U.S. and Canadian sites.
The FDA also provided further guidance on additional data views to be included in the planned NDA submission and continued to emphasize their focus on pharmacokinetic sustainability for a single dose. In addition, the FDA requested minor modifications to the Company's pediatric trial protocol.
The company said it has incorporated these FDA requested changes in the final pediatric trial protocol and do not expect these changes to have any significant impact on the planned timing of the pediatric trial.
Finally, the FDA noted that due to the new route of administration and the data supporting this route of administration, an advisory committee meeting may be necessary.
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