Neurology News Network for the week ending December 14, 2019.
This week Neurology News Network covered the 2019 American Epilepsy Society Annual Meeting. Some of the most pressing news came from a new CBD study on tuberous sclerosis complex, as well as the phase 3 study of funfluramine and the interim analysis of intranasal diazepam in seizure reduction.
Marco: Welcome to Neurology News Network. I’m Marco Meglio. This week NeurologyLive was on site for the 2019 American Epilepsy Society Annual Meeting. Here’s some highlights of our coverage.
Data suggest that cannabidiol can significantly reduce seizures associated with tuberous sclerosis complex (TSC), with similar efficacy observed between lower and higher doses. CBD was first approved in June 2018 as Epidiolex, making it the first drug approved by the FDA to contain a marijuana-derived, purified drug substance, as well as the first for the treatment of patients with Dravet syndrome. It is currently indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in those 2 years of age and older. Patients who were treated with cannabidiol 25 mg or 50 mg experienced seizure reductions of 49% and 48%, respectively, nearly double that of the placebo group, which experienced reductions of 27%.
Data from an open-label, phase 3 clinical study of adjunctive fenfluramine demonstrated an association between a significant reduction in convulsive seizure frequency and improvement in everyday executive function in patients with Dravet syndrome. In late November, the FDA accepted the new drug application for the oral solution of fenfluramine for the treatment of seizures associated with DS. Additional studies on the drug have shown that it can be an effective treatment option for patients with DS taking stiripentol who continue to have seizures. Fenfluramine oral solution is currently being evaluated by the FDA for the treatment of seizures associated with Dravet syndrome.
An interim analysis of a study of intranasal diazepam demonstrated a safety and tolerability profile consistent with what is expected for diazepam, regardless of usage frequency. In October, Neurelis reported that intranasal diazepam was safe and tolerable for the treatment of cluster or acute, repetitive seizures in pediatric patients with epilepsy. To better understand whether the safety and tolerability of intranasal diazepam would remain consistent with its previous safe and tolerable profile, investigators assessed patients based on how frequently they used the drug per month, noting “moderate” if a patient averaged 1-2 doses per month or “frequent” if a patient averaged >2 doses per month.
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