The U.S. Food and Drug Administration (FDA) gave its final approval to GW Pharmaceuticals' Epidiolex medication on Monday, completing a lengthy trial and review process. The FDA has okayed the sale of Epidiolex to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years old or older.
"We are very pleased to see the approval of EPIDIOLEX® for Dravet and Lennox-Gastaut syndromes", says Dravet Syndrome Foundation Executive Director Mary Anne Meskis. The regulator said that cannabidiol does not lead to intoxication or euphoria caused by tetrahydrocannabinol (THC), which is the main psychoactive component of marijuana.
In a study involving children with Dravet syndrome, five percent became seizure free while taking the drug compared to none in the placebo arm, and patients also had a significantly greater median reduction in convulsive seizures (39 percent) compared to placebo (13 percent).
Epidiolex is derived from cannabidiol, or CBD, an active chemical compound in marijuana that reduces the frequency of seizures.
"It's nice to have that the government hopefully will allow further research into CBD for not only epilepsy, but for a variety of other conditions". The FDA noted in its announcement today that it informs and advises the DEA about scheduled substances. Some of the side effects of treatment with Epidiolex included, among other, sleepiness, lethargy, diminished appetite, rashes, and infections.
FDA Commissioner Dr. Scott Gottlieb said in a statement, "This is an important medical advance".
Gaer said she's been using a particular CBD oil with her daughter since it's been legal in Iowa, and she's not sure about this new drug. The Schedule I classification deems the drug of high risk and minimal benefit, particularly for medical use. "This decision by the FDA puts another tool in the toolbox to treat people with Angelman syndrome". Indeed, the FDA has been trying to crack down on CBD producers who make claims that their products can cure diseases like cancer.
The company has not announced pricing for the drug, but Wall Street analysts previously predicted it could cost as much as $25,000 per year.
He said, "Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".
But he said that won't affect Epidiolex's approval, since individual drugs often receive their own schedule.