Sept. 28, 2018 — The Drug Enforcement Administration (DEA) has reclassified the epilepsy cannabidiol drug Epidiolex from Schedule I to Schedule V, paving the way to market for the cannabis-based treatment.
The FDA approved the drug in June to treat seizures associated with Lennox-Gastaut syndrome ( LGS) or Dravet syndrome in patients aged 2 years and older.
Schedule I is the most restrictive classification, and Schedule V is the last restrictive. Schedule I drugs have no accepted medical use and a high potential for abuse, according to the DEA. Medicines in Schedule V have a proven medical use and low potential for abuse.
The DEA says the change does not include marijuana or CBD that comes from marijuana. As Schedule I drugs, “they remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit,” it says in a news release. “In those instances, such as here, the drug will be made appropriately available to the public for medical use.”
Justin Gover, chief executive officer of GW Pharmaceuticals, said in a news release the company was hoping to make the drug available within the next 6 weeks.
People with Lennox-Gastaut syndrome often have seizures that begin as early as the age of 3. More than 75% of patients with the syndrome have tonic seizures, which cause their bodies, arms, or legs to become suddenly stiff and tense. Most children who have it develop intellectual disabilities, and many patients have problems with motor skills.
Dravet syndrome affects babies during their first year and causes frequent febrile seizures — those linked to fever. As the patient gets older, other types of seizures often happen, including those that need emergency treatment because they last too long. They also often have problems with language and motor skills.
Epidiolex was evaluated in three randomized, placebo-controlled studies in 516 patients with Lennox-Gastaut syndrome or Dravet syndrome. Results showed that add-on therapy with the drug was better than placebo in making the seizures happen less often.
The most common problems in Epidiolex-treated patients were sleepiness, a drop in appetite, diarrhea, a rise in the liver enzyme transaminase, fatigue, malaise, weakness, rash, insomnia, sleep disorder, poor-quality sleep, and infections.
Medscape Medical News
Sources
DEA: “FDA-approved drug Epidiolex placed in schedule V of Controlled Substance Act.”
Epilepsy Foundation.
News release, GW Pharmaceuticals.
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