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The Drug Enforcement Agency (DEA) awarded GW Pharmaceuticals& # 39; (NASDAQ: GWPH) epilepsy, Epidiolex, Appendix V status, its least restrictive classification. Decision allows GW Pharmaceuticals to start offering the only DEA-approved CBD oil for use across the country, and it puts the company on the brink of disrupting the way doctors treat patients who do not respond to drugs existing antiepileptics.
A DEA first
Marijuana has been a Schedule I controlled substance since the Congress passed the Controlled Substances Act in 1970 and the DEA Epidiolex decision does not change that. Yet it is the first time that the DEA recognizes that the cannabinoid, cannabidiol (CBD), chemical of marijuana, has health benefits.
SOURCE OF IMAGE: GETTY IMAGES.
The most common non-psychoactive cannabinoid in sativa cannabis plants, CBD oil has been used by patients in states that have allowed it for years because of anecdotal evidence of its ability to reduce seizures. However, it is only today that a CBD oil derived from marijuana has been recognized by the DEA and the Food and Drug Administration (FDA) for the benefit of patients with # 39; epilepsy.
The DEA's decision on Epidiolex is based on controlled scientific studies conducted by GW Pharmaceuticals demonstrating that Epidiolex can reduce monthly seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome, two difficult forms of arthritis. Epilepsy in the child. 40%.
Why planning is important
After reviewing GW Pharmaceuticals' clinical trial data, the FDA approved the use of Epidiolex in Dravet syndrome and Lennox-Gastaut syndrome patients in June, but GW Pharmaceuticals was unable to sell it to patients weighed with a planning decision.
The DEA may choose to program drugs in five categories. The most restrictive classification, Schedule I, includes drugs without "medical use currently accepted in the United States, a lack of accepted security for use under medical supervision and a high potential for abuse". Marijuana remains in this category alongside heroin, LSD and ecstasy.
The drugs from Schedule II to Schedule V have an accepted medical use. However, barriers to prescribing and filling drug prescriptions in these categories are steadily decreasing, with Schedule V being the least restrictive schedule category.
The approval of Epidiolex by the FDA has sparked a debate over the category in which it would end up.
Marinol, a drug long used to reduce chemotherapy-induced vomiting and nausea and to restore appetite in HIV-infected patients, is a Schedule III drug, while a liquid formulation approved more recently, Insys Therapeutics& # 39; (NASDAQ: INSY) Syndros is a Schedule II drug.
The worst case scenario for Epidiolex would have been Appendix II, as this classification requires written prescriptions and not prescriptions by physicians, and prohibits renewals without a separate new order. Most thought that Epidiolex would end up in Tables III or IV. Schedules III and IV authorize oral, written or fax orders and up to five refills within six months of the original prescription date.
Instead, Epidiolex has entered Schedule V, the least restrictive classification, which means that there are no obstacles to the prescription and its replacement over- beyond the prescriptions of the doctor. This places Epidiolex in the same category as cough medicines containing codeine such as Robitussin AC.
SOURCE OF IMAGE: GETTY IMAGES.
What to watch now for this stock of medical marijuana
The classification of Annex V only applies to Epidiolex, not to other CBD oils or products such as those manufactured by Tilray (NASDAQ: TLRY). Therefore, Epidiolex is the only prescription CBD formulation available nationwide.
GW Pharmaceuticals plans to launch Epidiolex in the coming weeks, and there is good reason to believe that its demand will be significant within approved limits. Most patients with Dravet syndrome and Lennox-Gastaut syndrome do not respond to other drugs and, as a result, they suffer significantly and need new therapeutic options like Epidiolex.
Initially, the current price of Epidiolex at launch should rise to $ 32,500. However, insurers will likely bear the brunt of this burden. In the United States, there are only about 30,000 patients with both types of epilepsy. The addressable market is therefore relatively small. Nevertheless, depending on the size of the discounts that insurers negotiate with GW Pharmaceuticals, it appears that Epidiolex has managed to generate annual sales of several hundred million dollars.
Over time, Epidiolex's earnings may be higher than this, however, if physicians prescribe it off-label for patients with difficult-to-treat seizures outside Dravet's syndrome and Lennox-Gastaut syndrome. . About one-third of the 2.2 million patients with epilepsy are inadequately controlled by existing drugs.
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