FDA Clears Clobazam Oral Film (Sympazan) for Lennox-Gastaut

Megan Brooks

November 02, 2018

The US Food and Drug Administration (FDA) has approved an oral film formulation of clobazam (Sympazan, Aquestive Therapeutics) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years and older, the manufacturer has announced.

Sympazan is the first oral film formulation of clobazam approved by the FDA to treat seizures associated with LGS.

"Many LGS patients have a hard time swallowing pills and suspensions. This can make administering medication hard for caregivers. We believe Sympazan will be welcomed by patients and caregivers impacted by LGS and searching for treatment solutions," Christina SanInocencio, executive director of the LGS Foundation, said in a news release from the manufacturer.

The FDA approved clobazam tablets and oral suspension as adjunctive treatment for LGS in 2011. Sympazan oral film has been shown to be bioequivalent to clobazam tablets and to have a comparable safety profile, the company said.

Sympazan oral film is berry flavored and comes in three strengths, 5 mg, 10 mg, and 20 mg. The manufacturer said it plans to make Sympazan available this month.

Adverse reactions with Sympazan (≥10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and drooling.

Sympazan contains a boxed warning noting that the concomitant use of benzodiazepines and opioids may lead to profound sedation, respiratory depression, coma, and death.

Concomitant prescribing of these drugs should be reserved for patients for whom alternative treatment options are inadequate. Patients should be monitored for signs and symptoms of respiratory depression and sedation. Sympazan is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients.

Full prescribing information for Sympazan is available online.

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