The Food and Drug Administration (FDA) approved an oral film formulation of clobazam (Sympazan, Aquestive Therapeutics) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years and older. Sympazan is the first oral film formulation of clobazam approved by the FDA to treat seizures associated 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.”
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.
Since FDA approval in 2011, clobazam tablets and oral suspension (brand name ONFI®) have been a trusted adjunctive treatment for LGS. In a Phase 3, randomized, double-blind, placebo-controlled study of 238 LGS patients, clobazam tablets significantly reduced the frequency of drop seizures (which involve falls) compared to baseline by 41 percent (low dose) to 68 percent (high dose) vs. 12 percent for placebo (p<0.05 for all doses vs. placebo). Please see more Important Safety Information below, including the Boxed Warning on the risks associated with concomitant use of opioids.
“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.”
“Sympazan is the beginning of a meaningful CNS franchise for Aquestive,” Kendall says. “We are actively working to advance more redesigned, proprietary treatments that can offer meaningful improvements for patients and caregivers who live with epilepsy and other complex conditions.”