The initial report of the US Expanded Access Program for fenfluramine indicates that those with Dravet syndrome treated with fenfluramine (Fintepla; Zogenix) have clinically meaningful responses similar to that observed in clinical trials.
The agency has assigned a PDUFA date of July 31, 2020, for the purified CBD treatment which has been previously approved for Dravet and Lennox-Gastaut syndromes.
SK Life Science’s newly approved treatment for partial-onset seizures is set to launch in the second quarter of 2020, after being designated Schedule V by the DEA.
The drug was previously approved for the treatment of acute repetitive seizures and granted 7 years of orphan drug exclusivity in January 2020.
An 8 year old boy with genetically confirmed neurofibromatosis type 1 presents with first generalized seizure.
A newborn presents with new onset episodes of lateral gaze deviation with extremity stiffening.
A boy diagnosed with glycine encephalopathy in the newborn period was initiated on the ketogenic diet at 11 years-old for the treatment of medication refractory epilepsy.
A generally healthy, young adult male presents with first generalized tonic-clonic seizure followed by episodes of violent psychosis.
The new drug application for Libervant is expected to be completed in the fourth quarter of 2019, which if approved, would offer a potentially first in class oral treatment for breakthrough or cluster seizures.
This patient had febrile seizures as a child but experienced no further events until the recent episode on an airplane. How would you proceed?