Aquestive Therapeutics, Inc. is a pharmaceutical company focused on discovering, developing, and commercializing products to address significant unmet medical needs across both the United States and international markets. The company's commercialized portfolio includes: Sympazan, an oral soluble film formulation of clobazam for individuals with Lennox-Gastaut syndrome. Suboxone, a sublingual film containing buprenorphine and naloxone, indicated for the treatment of opioid dependence. Zuplenz, an oral soluble film of ondansetron, used to manage nausea and vomiting associated with chemotherapy and post-operative recovery. Azstarys, a once-daily medication for attention deficit hyperactivity disorder. Aquestive maintains a robust proprietary pipeline of drug candidates. These include: Libervant, a buccal soluble film formulation of diazepam currently in development for the treatment of seizures. Exservan, an oral soluble film of riluzole, aimed at treating amyotrophic lateral sclerosis (ALS). Within its complex molecule pipeline, the company is advancing: AQST-108, a sublingual film designed to deliver systemic epinephrine for conditions other than anaphylaxis. AQST-305, a sublingual film formulation of octreotide for managing acromegaly. AQST-109, an orally administered epinephrine product candidate intended for the emergency treatment of severe allergic reactions, including anaphylaxis. Furthermore, Aquestive Therapeutics played a role in the development of KYNMOBI, a sublingual film formulation of apomorphine, used to address episodic "off" periods in patients with Parkinson's disease. Established in 2004, Aquestive Therapeutics, Inc. is headquartered in Warren, New Jersey.
Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027
The FDA accepted Aquestive's resubmission of the Anaphylm NDA as complete and assigned a Class 2 PDUFA goal date of March 16, 2027.
The resubmission, filed September 16, 2026, followed positive human factors and pharmacokinetic study results addressing the FDA's January 30, 2026 Complete Response Letter.
If approved, Anaphylm would be the first and only oral rescue medication for severe allergic reactions, including anaphylaxis; the company is also on track to file its New Drug Submission with Health Canada in Q4 2026.