FDA approves Sympazan for Lennox-Gastaut syndrome.- Aquestive Therapeutics.

Aquestive Therapeutics announced that the 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.

In a Phase III, 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).>

Comment: Sympaza (clobazam) oral film received tentative approval by the FDA in August 2018, for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older. Up till then, clobazam was marketed as Onfi and offered in two formulations - either tablet or oral suspension. Final FDA approval for Sympazan had to wait for the expiration of the orphan drug exclusivity period for Onfi.