Aquestive Therapeutics introduced that the Meals and Drug Administration (FDA) didn’t approve Anaphylm™, an under-the-tongue epinephrine movie for treating extreme allergic reactions, right now. As a substitute, the FDA despatched a Full Response Letter (CRL) asking for modifications earlier than approval can transfer ahead.
A CRL does not imply a drug is unsafe or rejected eternally. It means the FDA reviewed the appliance and wishes extra data or modifications earlier than it could possibly approve the drugs. Firms can tackle the problems and resubmit their utility.
On this case, the FDA’s issues give attention to ease of use, corresponding to bother opening the bundle and putting the movie accurately. These points may very well be dangerous throughout anaphylaxis. To repair this, the corporate should replace the packaging, directions, and labeling. With these updates, the corporate additionally should run a brand new examine to verify the up to date packaging is straightforward to make use of and carry out 1 small drug stage examine to substantiate these modifications don’t have an effect on how the drugs works. No different security, manufacturing, or effectiveness issues have been raised.
Aquestive plans to fulfill with the FDA quickly and expects to resubmit its utility in late 2026. The corporate stays assured Anaphylm might turn out to be a brand new, needle-free epinephrine choice for individuals with meals allergy symptoms.
Medical Overview: February 2026 by Matthew Greenhawt, MD, MBA, MSc
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