Oral Film Formulation of Clobazam Gets FDA Approval for LGS
Aquestive Therapeutics announced that the FDA has approved Sympazan oral film as adjunctive treatment of seizures associated with LGS in patients aged ≥2 years old.
Aquestive Therapeutics announced that the FDA has approved Sympazan oral film as adjunctive treatment of seizures associated with LGS in patients aged ≥2 years old.
Better social competence and adaptive behavior was achieved by seizure-free patients at post-surgery follow-ups compared with patients with persistent seizures (P <.05).
Clobazam is currently available as oral tablets and suspension under the trade name Onfi (Lundbeck).
This marks the first approved drug that contains an active ingredient derived from marijuana as well as the first treatment approved for patients with Dravet syndrome.
Add-on cannabidiol is associated with reduced monthy drop seizure frequency in patients with Lennox-Gastaut sydrome associated drop seizures.
The FDA has accepted for filing with Priority Review the NDA for cannabidiol as seizure treatment.
Clobazam is currently FDA-approved for the treatment of seizures associated with Lennox-Gastaut syndrome in children 2 years and older.
The study was a post-hoc analysis of responders who were on or off concomitant clobazam.
Adverse reactions in the CBD group included decreased appetite, diarrhea, fatigue, lethargy, nasopharyngitis, pneumonia, pyrexia, rash, and somnolence.
Anup Patel, MD, of Nationwide Children’s Hospital and The Ohio State University School of Medicine, discusses findings from a dose-ranging study of cannabidiol for the treatment of drop seizures in Lennox-Gastaut syndrome. Scroll to below the video for a full text transcript of Dr Patel’s interview.