Clobazam Oral Film Approved For Treatment of Lennox-Gastaut Syndrome

Monday, November 05, 2018

The Food and Drug Administration (FDA) has approved an oral film clobazam (Sympazan; Aquestive Therapeutics, Warren, NJ) for the adjunctive treatment of seizures in patients, age 2 years and up, with Lennox-Gastaut syndrome (LGS). Clobazam tablets and oral suspension (Onfi; Lundbeck, Deerfield, IL) have been available since clobazam was approved the FDA in 2011 as adjunctive treatment for people with LGS. 

Patients with LGS often have both frequent seizures and intellectual disabilities, making pill formulations difficult to administer, especially in patients who may be combative or resistant to treatment. This new formulation is expected to ease caregiver burden and improve adherence to treatment by providing another option for patients with LGS.  

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

“Many LGS patients have a hard time swallowing pills and suspensions. This can make administering medication hard for caregivers,” says Christina SanInocencio, Executive Director of the LGS Foundation. “We believe Sympazan will be welcomed by patients and caregivers impacted by LGS and searching for treatment solutions.”

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