The Acting Administrator of the Drug Enforcement Administration has placed FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols (THC) in schedule V. GW Pharmaceutical’s (GWPH) Epidiolex had been a schedule I controlled substance, with this new directive Epidiolex (and any generic versions of the same formulation that might be approved by the FDA in the future) will be a schedule V controlled substance.
Schedule five drugs are considered to have a low level of abuse and include substances like Robitussin cough syrup or Lomotil diarrhea medicine.
The order made it clear that other cannabis products would remain in the schedule 1 category. The statement said, “As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.” The document is scheduled to be published on September 28, 2018.
The order also said, “Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in
treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.”
The order went on to stress that CBD material, “which includes, among other things, a drug product containing CBD extracted from the cannabis plant, is a Schedule I drug under the Single Convention.”
Dr. George E. Anastassov, Chief Executive Officer of AXIM Biotechnologies remarked, “Today’s news is an important step for the pharmaceutical cannabinoid industry. It signifies an understanding on behalf of the regulatory agencies in the United States, such as the FDA and DEA, that cannabidiol (CBD) has therapeutic potential and a very low potential for abuse and misuse. However, this applies ONLY to Epidiolex, i.e. to the molecule contained within this particular formulation. Otherwise, CBD still remains as a Schedule I controlled substance and the current classification is non-applicable to the rest of the products available on the market.”
Thoma Kikis, Chief Communications Officer of Kannalife Sciences said, “The DEA’s rescheduling of Epidiolex from a Schedule I to a Schedule V controlled substance gives cannabidiol (CBD) more credibility and recognition as a treatment in the U.S. that does, in fact, have medical value. This is a watershed moment for the cannabinoid industry, and very encouraging for Kannalife Sciences and the work we have done to research and develop our own CBD-derived molecule (KLS-13019) for the treatment of diseases with unmet medical needs, such as Chemotherapy-Induced Neuropathic Pain (CINP), Hepatic Encephalopathy (HE), and Chronic Traumatic Encephalopathy (CTE). However, there is still more work to be done.”
GW Pharmaceutical stock jumped over 8% on the news to lately trade at $176.