Founded in 1998, GW Pharmaceuticals PLC is biopharmaceutical company that primarily focuses on the the discovery and commercialization of novel therapeutics developed from its proprietary cannabinoid product platform. On June 25, 2018, GW Pharmaceuticals became the first company to successfully bring to market a cannabidiol (CBD) based drug. The path for the drug's approval was largely cleared in early April when the Peripheral and Central Nervous Drugs Advisory Committee of the US Food and Drug Administration recommended supporting the approval of the company’s new drug known as Epidiolex.
Epidiolex is a cannabidiol oral solution and is recommended for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome patients. Recently, GW Pharmaceuticals PLC announced that the first FDA-approved prescription CBD Oil will cost $32,500 per year. The approval of Epidiolex can affect significant change in the cannabis community as the FDA’s approval of the drug is at direct odds with CBD’s federal status as a Schedule I (Class I) drug. Schedule I drugs are classified as such because they are considered to have a high potential for abuse, no medical use, and severe safety concerns.
The approval of Epidiolex is tantamount to tacit admission of the medicinal value of cannabis-derived phytocannabinoids like CBD. The DEA will reschedule CBD by the Fall in order to uphold the Controlled Substances Act. With its current status as Schedule I, the FDA cannot bring Epidiolex to market, so a rescheduling is imminent. Barbara Carreno, a spokeswoman for the DEA, reported to Business Insider that the agency has 90 days from the FDA approval to put CBD into a lower classification. GW Pharmaceuticals PLC has requested a rescheduling to III or IV; Barbara Carreno admitted with the FDA’s approval the DEA must take action. “We don’t have a choice on that. It absolutely has to become Schedule II or III.”
Rescheduling CBD would resolve much of the current conflict between the outdated laws currently in place and cannabidiol’s (CBD) arrival on the scene as the media’s wonder-cannabinoid. With CBD’s expected rescheduling and the enormous potential of the latest farm bill championed by Kentucky’s Mitch McConnell, 2018 is shaping up to be one of the most significant years on record for Hemp.