The U.S. Food and Drug Administration has accepted for review a New Drug Application for clobazam Oral Soluble Film (clobazam OSF) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older. The target date for completion of the FDA review is the third-quarter of 2018.
Clobazam OSF is administered using Aquestive’s PharmFilm drug delivery technology. Similar in size and thickness to a stamp, Aquestive’s PharmFilm dissolves instantly after being placed on the tongue and can be administered without water.
Two multicenter controlled studies were conducted to evaluate the bioequivalence of clobazam OSF with clobazam tablets, a benzodiazepine currently on market, at the same dosage strengths. Based on the studies, clobazam OSF was demonstrated to be bioequivalent to clobazam tablets and have comparable safety.