Epilepsy

Fycompa Granted Priority Review for Pediatric Indications

By May 30, 2018

The sNDA included data from Study 311 (N=180), an ongoing, open-label, multicenter trial with an extension phase that evaluated the safety, tolerability, and exposure-efficacy relationship of Fycompa oral suspension as adjunctive therapy in children (4 to 11 years) with inadequately controlled POS or PGTC seizures.

Briviact Approved for Pediatric Patients With Partial-Onset Seizures

By May 14, 2018

The expanded approval was supported by extrapolated efficacy data from placebo-controlled studies in adults with partial-onset seizures.

FDA Committee Votes in Favor of Cannabidiol Oral Solution for LGS, Dravet Syndrome

By April 20, 2018

Epidiolex added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.

Fycompa sNDA Submitted for Pediatric Seizure Indications

By March 30, 2018

The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years.

Splitting Adult-Dose AED Tablets for Children: Is it Effective?

By December 28, 2016

Study authors analyzed 1,098 split tablet parts among 168 caregivers.

Risk of Birth Defects with Antiepileptic Drug Combos Examined

By June 08, 2016

New research suggests that the antiepileptic drug (AED) topiramate, when used in combination with other AEDs (excluding valproate) may enhance its propensity to cause fetal malformation.

Cannabidiol Shows Promise in Pediatric Epilepsy

December 08, 2015

(HealthDay News) — Cannabidiol might benefit some children with epilepsy whose seizures aren't controlled by approved medications, according to research scheduled to be presented at the annual meeting of the American Epilepsy Society, held from December 4 to 8 in Philadelphia.