FDA accepts Aquestive Therapeutic’s NDA for clobazam OSF treating LGS patients

Aquestive Therapeutics proclaimed the acceptance of New drug application for clobazam Oral Soluble Film (clobazam OSF) treating seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older by the US Food and Drug Administration for evaluation scheduled for completion in the third- quarter of 2018 as stated by the PDUFA (Prescription Drug User Fee Act). 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.

Keith J. Kendall, Chief Executive Officer of Aquestive commented “The FDA acceptance of clobazam OSF is a significant step toward our goal of bringing patients an important new option for this rare form of epilepsy.”