ARS Pharmaceuticals Inc. (NASDAQ:SPRY) filed a petition Monday urging the FDA to delay approval of Aquestive Therapeutics Inc.'s (NASDAQ:AQST) experimental epinephrine treatment, citing safety, dosing, and real-world use concerns.
The filing requests that the FDA withhold approval of AQST-109, a sublingual film branded as Anaphylm. If cleared, ARS wants a boxed warning highlighting potential cardiovascular risks.
ARS argues that current data does not sufficiently demonstrate the drug's safety or efficacy for anaphylaxis patients. The company requested additional studies to address usability and pharmacological concerns.
ARS recommended a real-world safety and usability trial with allergy patients. The goal is to assess whether AQST-109 can be reliably absorbed during severe reactions. The firm also called for closer study of the drug's prodrug components and metabolites. It stated that unusual diastolic blood pressure spikes were not seen with other epinephrine formulations.
The petition urged a pharmacokinetic study of repeated dosing at five-minute intervals to prevent risks from overexposure. ARS warned that approval without such data would be premature and, if cleared, a boxed warning should highlight potential cardiovascular complications.
Citing the FDA's authority under the Food, Drug, and Cosmetic Act to delay approval for safety, ARS noted Aquestive's previous Complete Response Letter for its diazepam buccal film, Libervant, and said AQST-109 poses even greater risks, delivering epinephrine at three times the minimally lethal injection threshold.
Aquestive submitted its marketing application for AQST-109 on April 1, 2025, with a PDUFA action date of January 31, 2026.
ARS maintains that, until further research is completed, the application should not move forward.
Price Action: SPRY stock is up 1.89% at $9.98, and AQST stock is up 4.64% at $5.41 at the last check on Tuesday.
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