UPDATED September 28, 2018 // The US Drug Enforcement Administration (DEA) has rescheduled the epilepsy cannabidiol (CBD) drug Epidiolex (GW Pharmaceuticals) from Schedule I to Schedule V, the classification with the lowest degree of restriction — paving the way to market for the cannabis-based treatment, the company has announced.
As reported by Medscape Medical News, the US Food and Drug Administration (FDA) approved the drug in June for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients aged 2 years and older. The approval followed a unanimous thumbs up by an FDA advisory committee in April.
"We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians," Justin Gover, GW's chief executive officer, said in a news release.
"With this final step in the regulatory process completed, we are working hard to make Epidiolex available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA," said Gover.
In its own release, the DEA emphasized that the rescheduling is only for this particular product. "Marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit. In those instances, such as here, the drug will be made appropriately available to the public for medical use," the DEA stated.
Schedule V Designation
Medicines in Schedule V have a proven medical use and low potential for abuse. The DEA's decision to move Epidiolex to Schedule V was based on nonclinical and clinical data regarding its potential for abuse, the company said.
Patients with LGS often have seizures that begin as early as age 3 years. More than 75% of patients with the syndrome experience tonic seizures. Most children with it develop intellectual disabilities, and many patients have motor skill impairments.
Dravet syndrome affects babies during the first year of life and causes frequent febrile seizures. As the patient ages, other types of seizures often occur, as does status epilepticus. These children also often have language and motor skill dysfunction.
Epidiolex was evaluated in three randomized, placebo-controlled studies in a total of 516 patients with LGS or Dravet syndrome. Results showed that add-on therapy with the drug was more effective than placebo in reducing seizure frequency.
Because of these "well-controlled" trials, which were published in the New England Journal of Medicine and Lancet, "prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes," FDA Commissioner Scott Gottlieb, MD, said at the time in a news release announcing the agency's approval.
The most common adverse reactions that occurred in Epidiolex-treated patients were somnolence, decreased appetite, diarrhea, elevations in transaminase level, fatigue, malaise, and asthenia, rash, insomnia, sleep disorder, poor-quality sleep, and infections.
Medscape Medical News © 2018
Cite this: DEA Reschedules Epidiolex, Paving the Way to Market - Medscape - Sep 27, 2018.