Final approval for Sympazan, the oral soluble film formulation of clobazam, is pending the expiration of the orphan drug exclusivity period for ONFI.
Officials with the FDA granted tentative approval for Sympazan, Aquestive Therapeutics’ oral soluble film formulation of clobazam, as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age and older, according to a press release.
Clobazam is currently marketed as ONFI and offered in either tablet or oral suspension formulations. The latest oral soluble film formulation will be delivered via Aquestive’s proprietary PharmFilm technology.
LGS is a rare, severe form of epilepsy that typically forms early in childhood. Individuals with the disease often experience multiple types of seizures and intellectual disability, which can lead to difficulty swallowing pills and large volume suspensions.
“We saw a need in the LGS community for a simpler, more consistent way to administer a full dose of clobazam — and we are now 1 step closer to bringing this important treatment to patients, caregivers, and physicians,” Keith J Kendall, chief executive officer of Aquestive Therapeutics, said in a press release. “This tentative approval for Sympazan is a key milestone for Aquestive, as it presents the first in a series of late stage proprietary products Aquestive plans to commercialize once they are approved.”
The tentative approval is based on multiple clinical studies comparing Sympazan with ONFI. Results of these studies showed that the oral film demonstrated to be bioequivalent to clobazam tablets and have comparable safety.
According to Aquestive, final approval for Sympazan is pending the expiration of the orphan drug exclusivity period for ONFI, which is expected in October 2018.
Aquestive Therapeutics Announces Tentative FDA Approval for Sympazan™ (clobazam) Oral Film [news release]. Aquestive Therapeutics’ website. https://aquestive.com/single-news?post=6686. Accessed September 4, 2018.