In June 2018, The Food and Drug Administration (FDA) for the first time approved a component derived from marijuana, called Epidiolex, for medical treatment of epilepsy.
Epidiolex is essentially a pharmaceutical-grade version CBD oil. This strawberry-flavored syrup is a purified form of CBD (CBD is a component found in cannabis but does not contain THC i.e. it does not makes the user high) used to treat two rare forms of epilepsy – Dravet and Lennox-Gastaut syndromes that begin in childhood. FDA officials said the drug reduces seizures when combined with older epilepsy drugs.
Epidiolex, the first of its kind drug to be legalized federally, is obviously not going to be cheap. According to GW Pharmaceuticals, Epidiolex would cost roughly $32,500 per year.
Julian Gangolli, who leads the company’s commercialization efforts in the US said that though not cheap, the price of the drug would be on par with other epilepsy medications.
According to Julian Gangolli, despite its high price tag — it would ultimately be cheaper than buying hemp-derived CBD products online or CBD medication from a medical cannabis dispensary. Gangolli added that with insurance, Epidiolex could be substantially cheaper than dispensary CBD. However, many patients are expected to continue opting into the more loosely regulated gray market.
Gangolli also said that patients should expect a wait time of about three weeks between – when a physician prescribes the medication to when they actually receive the drug.
But before any prescriptions for Epidiolex can be written, the Drug Enforcement Administration must reschedule its active ingredient – CBD. DEA has 90 days starting with June 25, when Epidiolex was approved, to reschedule or re-classify CBD as a schedule 2, 3, 4, or 5 substance. For now, CBD remains a Schedule 1 drug with “no currently accepted medical use.”
FDA Commissioner Scott Gottlieb said in a statement –“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,”