Epidiolex First Drug with CBD to Gain FDA Approval
June 25, 2018 – The U.S. FDA has approved Epidiolex® (cannabidiol) oral solution, manufactured by GW Pharmaceuticals. The product is indicated to treat seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients at least two years of age. This marks the first FDA approval of a medication that contains an active ingredient derived from the Cannabis sativa (marijuana) plant.
LGS and Dravet syndrome are rare forms of severe, hard-to-treat epilepsy that begin in early childhood. Both often lead to significant developmental delays, and can be fatal early on. Epidiolex is the first in a new category of antiepileptic drugs, and the first FDA-approved treatment for Dravet syndrome. In clinical studies, it reduced the occurrence of seizures compared to placebo when used alongside other antiepileptic therapies.
A chemical component that naturally occurs in C. sativa, cannabidiol (CBD) does not cause intoxication or euphoria (a “high”) when taken. These effects are caused by tetrahydrocannabinol (THC), which Epidiolex does not contain.
Because marijuana is considered a Schedule I controlled substance in the United States, the Drug Enforcement Administration (DEA) must review and reschedule Epidiolex before the product can be launched. The DEA’s decision is expected within three months of the FDA approval.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.