FDA Tentatively Approves Sympazan Oral Film

Aquestive Therapeutics announced that Sympazan (clobazam) oral film has received tentative approval by the U.S. Food and Drug Administration (FDA), for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older. Currently, clobazam is marketed as ONFI and offered in two formulations - either tablet or oral suspension.

"We saw a need in the LGS community for a simpler, more consistent way to administer a full dose of clobazam - and we are now one step closer to bringing this important treatment to patients, caregivers and physicians," said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. "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. We believe Sympazan and our other products in development solve important therapeutic problems, and will meaningfully improve the lives of patients and their caregivers."

Lennox-Gastaut Syndrome is a severe form of epilepsy that begins in early childhood and is characterized by multiple types of seizures and intellectual disability. LGS patients often have difficulty swallowing pills and large volume suspensions due to physical limitations, behavioral or compliance issues. Challenges with treatment administration can lead to uncertain and inconsistent dosing, and increase the burden of care, particularly for patients that may be combative or resistant to treatment.

Sympazan is a proprietary formulation based on Aquestive's proven PharmFilm technology. Multiple pharmacokinetic studies were conducted to compare Sympazan with ONFI. Based on the studies, Sympazan oral film was demonstrated to be bioequivalent to clobazam tablets and have comparable safety.

Final FDA approval for Sympazan is pending the expiration of the orphan drug exclusivity period for ONFI, which is expected in October 2018.

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