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.
Epilepsy and Seizure
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.
This additional application, supported by data from the GWPCARE6 trial, seeks to expand the indication of cannabidiol to include seizures associated with tuberous sclerosis complex.
No progressive or delayed complications of treatment were recorded after 3 years in patients with essential tremor who underwent focused ultrasound.
SK Life Science’s sodium channel antagonist cenobamate was approved based on data from pivotal trials in nearly 2000 patients in which it reduced the median number of seizures per 28 days.
Rodney Allan Radtke, MD, professor of neurology at Duke University School of Medicine in Durham, North Carolina, discussed some of the new therapeutic options available to help improve tolerance and adherence challenges that clinicians commonly face in epilepsy practice.
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.
Patients with drug-resistant seizures should have an epilepsy center evaluation to confirm the diagnosis and determine the epilepsy syndrome and possible candidacy for neurosurgery. Guidelines here.
Patients with epilepsy often seek CAM therapies—with or without the recommendations or explicit approval of their neurologist.