Aquestive Therapeutics Inc. announced that the U.S. Food and Drug Administration has accepted for review the company's New Drug Application for clobazam Oral Soluble Film for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older. LGS accounts for about 4% of all cases of childhood epilepsy.i The PDUFA target date for completion of the FDA review is the third-quarter of 2018. Clobazam OSF is administered using Aquestive's proprietary 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, among other benefits. 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.