WARREN, N.J., January 18, 2018 – Aquestive Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application for clobazam Oral Soluble Film (clobazam OSF) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. LGS accounts for about four percent of all cases of childhood epilepsy.[i] The PDUFA (Prescription Drug User Fee Act) target date for completion of the FDA review is the third-quarter of 2018.
“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,” said Keith J. Kendall, Chief Executive Officer of Aquestive. “Additionally, this is the first drug product we are independently commercializing, and we look forward to bringing the epilepsy community this much-needed improvement to a trusted and proven medication.”
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.
About Aquestive Therapeutics, Inc.
Aquestive Therapeutics, Inc. is a specialty pharmaceutical company that advances and commercializes medicines to solve critical healthcare problems and meaningfully improve people’s lives. Aquestive is committed to addressing immediate CNS challenges by furthering its strong pipeline of products. As the undisputed leader in developing and delivering drugs via its proprietary technologies, the Company also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms. For more information, please visit aquestive.com.
[i] U.S. National Library of Medicine. Lennox-Gastaut Syndrome. https://ghr.nlm.nih.gov/condition/lennox-gastaut-syndrome#statistics. Accessed January 2018.