Aquestive Therapeutics Announces U.S. FDA Filing Acceptance of NDA for Clobazam Oral Soluble Film to Treat Lennox-Gastaut Syndrome
WARREN, N.J., Jan. 18, 2018 /PRNewswire/ -- Aquestive Therapeutics 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.
i U.S. National Library of Medicine. Lennox-Gastaut Syndrome. https://ghr.nlm.nih.gov/condition/lennox-gastaut-syndrome#statistics. Accessed January 2018.
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SOURCE Aquestive Therapeutics