FDA Approves First Clobazam Oral Film for Lennox-Gastaut Syndrome

Officials with the FDA have approved Aquestive Therapeutics’ clobazam (Sympazan) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years and older, according to a press release.

Clobazam was previously marketed as Onfi and offered in either tablet or oral suspension formulations. This approval marks the first and only oral film approved by the FDA to treat seizures associated with LGS, according to Aquestive.

Clobazam oral film previously received tentative FDA approval in September based on multiple clinical studies comparing the oral film formulation with Onfi.

LGS is a rare, severe form of epilepsy that typically manifests early in childhood and causes multiple types of seizures and intellectual disability. Often, individuals with the disease have difficulty swallowing pills and large volume suspensions, which can lead to inconsistent dosing and increased burden of care.

“Many LGS patients have a hard time swallowing pills and suspensions. This can make administering medication hard for caregivers,” Christina Sanlnocencio, executive director of the LGS foundation, said in a statement. “We believe Sympazan will be welcomed by patients and caregivers impacted by LGS and searching for treatment solutions.”

Clobazam oral film, which was developed following the 505(b)(2) regulatory pathway, was shown to be bioequivalent to clobazam tablets and have comparable safety profiles, according to Aquestive.

The efficacy of clobazam tablets and oral suspension has been established in clinical studies. In a phase 3 study of 238 patients with LGS, data showed that clobazam tablets significantly reduced the frequency of drop seizures compared with baseline by 41% (low dose) to 68% (high dose) versus 12% for placebo.

The latest oral soluble film formulation will be delivered via Aquestive’s proprietary PharmFilm technology, according to the release. The oral film is berry-flavored and offered in 5 mg, 10 mg, and 20 mg dosages.

Aquestive announced they are on track to launch clobazam oral film in November 2018.

References

Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Approval for SYMPAZAN™ (clobazam) Oral Film [news release]. Aquestive Therapeutics’ website. https://aquestive.com/single-news?post=6776. Accessed November 2, 2018.