WARREN, N.J. – Aquestive Therapeutics announced that the U.S. Food and Drug Administration (FDA) approved Sympazan (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Sympazan is the first and only oral film FDA-approved to treat seizures associated with LGS. Previously, clobazam was marketed as Onfi and offered in two formulations – either tablet or oral suspension.
“Aquestive Therapeutics is pleased to bring Sympazan to the LGS community,” said Keith Kendall, chief executive officer of Aquestive Therapeutics. “Treating LGS can be difficult; patients may have a hard time swallowing oral medications. We’re optimistic Sympazan can help address unmet medical needs and be an important treatment option for this patient population.”
LGS 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 cognitive impact. 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.