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# Aquestive Therapeutics NDA for Seizure Drug Approved
- URL: https://www.fdaweb.com/aquestive-therapeutics-nda-for-seizure-drug-approved/
- Published: 2018-11-02T12:00:00.000Z
- Updated: 2026-09-15T00:42:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142731

FDA has approved an Aquestive Therapeutics NDA for Sympazan (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. According to the company, Sympazan is the first oral film FDA-approved to treat seizures associated with LGS. Previously, clobazam was marketed as Onfi in two formulations (tablet and oral suspension).

  
LGS patients often have difficulty swallowing pills and large volume suspensions due to physical limitations, behavioral or cognitive impact, the company says. Sympazan is a formulation based on Aquestive’s PharmFilm technology. Multiple pharmacokinetic studies were conducted to compare Sympazan with Onfi, and data demonstrated the oral film to be bioequivalent to clobazam tablets and comparable safety profiles, the company says.