Aquestive Therapeutics announced that the Food and Drug Administration (FDA) has approved Sympazan (clobazam) oral film as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged ≥2 years old. The product was first granted tentative approval by the FDA in September 2018, and is now the first oral film formulation of clobazam to be approved for the treatment of seizures associated with LGS.
Clobazam, a benzodiazepine, is currently available as tablets and as an oral suspension marketed under the trade name Onfi (Lundbeck). It is thought to work by potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABAA receptor. Sympazan utilizes the Company’s PharmFilm technology which allows for a potentially faster onset of action while minimizing gastrointestinal adverse effects. In comparative pharmacokinetic studies, Sympazan proved to be bioequivalent to clobazam tablets with comparable safety profiles.
Sympazan will be available as 5mg, 10mg, and 20mg strength berry-flavored oral films in 60-count packages. The product is anticipated to launch in November 2018.
For more information call (877) 394-5045 or visit Aquestive.com.