18 January 2018 - Aquestive Therapeutics today announced that the U.S. FDA 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 (LGS) in patients two years of age or older. 

Lennox-Gastaut syndrome accounts for about four percent of all cases of childhood epilepsy. The PDUFA (Prescription Drug User Fee Act) target date for completion of the FDA review is the third-quarter of 2018.

Two multi-centre controlled studies were conducted to evaluate the bioequivalence of clobazam oral soluble film (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.

Read Aquestive Therapeutics press release