fda-approval-letter
PHARMACY

FDA approved clobazam oral film formulation

BY Sandra Levy

Specialty pharmaceutical company Aquestive recently announced that it had received Food and Drug Administration approval for Sympazan — an oral film formulation of clobazam, which is indicated as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome, or LGS, in patients age 2 years old or older.

Previously, clobazam, which has the brand name Onfi, has only been available in tablet and oral suspension formulations. Sympazan is the first and only oral film that is FDA-approved to treat seizures associated with LGS, the company said.

Sympazan is berry flavored and is available in 5-, 10- and 20-mg dosages.

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.

“Aquestive Therapeutics is pleased to bring Sympazan to the LGS community,” Aquestive Therapeutics CEO Keith Kendall said. “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.”

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