By Padmanabhan Ananthan
Feb 2 (Reuters) – Aquestive Therapeutics said on Monday the U.S. FDA has declined to approve its oral drug for severe allergic reactions due to packaging issues, marking a setback to its efforts to enter the allergy market with an alternative for patients.
The New Jersey-based drugmaker was seeking approval for Anaphylm, its under-the-tongue film for allergic reactions, including anaphylaxis, a potentially life-threatening response to allergens like foods, stings or drugs.
The drug aims to compete directly with ARS Pharmaceuticals’ needle-free nasal spray Neffy, as an alternative to epinephrine auto-injectors like EpiPen that act quickly to open airways and stabilize blood pressure in emergencies.
The U.S. Food and Drug Administration’s so-called complete response letter cited packaging and use issues from a study where some users struggled to open the pouch or place the film, risking safety in emergencies, Aquestive said.
The regulator had first flagged deficiencies in the treatment’s labeling last month.
The company said it can resolve the deficiencies and expects to resubmit the application as early as the third quarter of 2026.
Shares of the company rose over 43% in morning trading to $4.22.
“We think the stock would have faced far more negative pressure today if we hadn’t previously been aware of the deficiencies letter,” Cantor analyst Kristen Kluska said.
The company said it has modified the pouch opening, instructions and labels, and plans a new user study.
Aquestive said the FDA has asked for one additional blood-sample study to check whether the packaging and labeling changes affect how the drug is consumed, absorbed and stays in the body.
“We do think there is a path forward in place to lead to an ultimate approval. We are confident that once these items are addressed, the FDA will be satisfied with the entire package.” Kluska added.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shilpi Majumdar and Shinjini Ganguli)
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