Aquestive Therapeutics Launches Sympazan

Aquestive Therapeutics has launched Sympazan (clobazam) oral film with availability nationwide through retail pharmacies and mail order. Sympazan is the first and only oral film approved by the FDA to treat seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

"The commercial launch of Sympazan represents an important milestone for Aquestive Therapeutics and marks the deployment of a dedicated sales team and establishment of a nationwide distributor network. Sympazan is designed to address unmet medical needs and we are pleased that people within the LGS community can now easily access this important treatment option," said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. "Managing LGS is challenging and we wanted to make sure filling a prescription for Sympazan didn't add to a family's burden, which is why we worked to establish an extensive distribution network."

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.

Sympazan is a formulation based on Aquestive's proven PharmFilm technology. Multiple pharmacokinetic studies were conducted to compare Sympazan with clobazam tablets and oral suspension (brand name ONFI). Based on the studies, Sympazan oral film was demonstrated to be bioequivalent to clobazam tablets and have comparable safety profiles. Please see more Important Safety Information below, including the Boxed Warning on the risks associated with concomitant use of opioids.

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.

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