The first marijuana-based drug in the United States has finally received FDA approval.
On Monday, the Food and Drug Administration announced the approval of the country’s first prescribed marijuana-based drug. The drug, which is known as Epidiolex is sourced from the “plant-derived oral solution of cannabidiol (CBD).”
The drug was approved for the treatment of seizures caused by two rare and severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. Epidiolex is the first FDA-approved drug that contains CBD, a purified substance sourced from marijuana.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” Scott Gottlieb, FDA’s current commissioner, said in a statement.
“Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, 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.”
Gottlieb went on to say that the FDA will support further scientific studies involving the therapeutic potential of marijuana-derived products. However, the commissioner also noted that the agency is prepared to take the necessary actions should CBD-containing products with unproven medical claims get illegally marketed in the country.
Before getting FDA-approved, Epidiolex was tested on over 500 patients with either Lennox-Gastaut syndrome or Dravet syndrome to ensure its effectiveness. The drug was found to be effective in reducing the seizure frequency when taken with other medications as compared to placebo.
Although it does sometimes cause minor side-effects such as lethargy and light-headedness, this could be a gateway drug for the medical marijuana industry.