FDA Grants Tentative Approval to Clobazam Oral Film for Lennox-Gastaut Syndrome

The US Food and Drug Administration (FDA) has granted a tentative approval to Aquestive Therapeutics, Inc.’s clobazam (Sympazan) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.

"This tentative approval for Sympazan is a key milestone for Aquestive, as it represents the first in a series of late stage proprietary products Aquestive plans to commercialize once they are approved,” said Keith J. Kendall, chief executive officer of Aquestive Therapeutics, in a recent statement. “We believe Sympazan and our other products in development solve important therapeutic problems and will meaningfully improve the lives of patients and their caregivers."

Sympazan is a proprietary formulation based on the company’s PharmFilm technology. Recent pharmacokinetic studies compared the oral film with clobazam tablets and found the film to be bioequivalent to the tablets, with comparable safety.

LGS is a rare and severe form of epilepsy characterized by multiple types of seizures and intellectual disability; it most commonly begins in early childhood between ages 3 and 5. Due to challenges with swallowing pills, behavioral, and compliance issues, LGS patients often face treatment administration challenges, which sometimes leads to uncertain or inconsistent dosing.

Final FDA approval for Sympazan is pending the estimated October 2018 expiration of the orphan drug exclusivity period for clobazam tablets.