Aquestive Therapeutics announced 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 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.
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Since FDA approval in 2011, clobazam tablets and oral suspension 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," said 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 a 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 profiles. Aquestive's clinical development of Sympazan followed the 505(b)(2) regulatory pathway.
"Sympazan is the beginning of a meaningful CNS franchise for Aquestive," Kendall said. "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."
Aquestive plans to commercialize Sympazan in November, and has engaged Ashfield Healthcare, a company specializing in commercialization services, to build and train a highly qualified, national sales force. The sales force will focus on pediatric neurologists and epileptologists.
Sympazan oral film is berry flavored and offered in 5 mg, 10 mg, and 20 mg dosages to meet a range of LGS patient and caregiver needs.