Could Epidiolex Launch in 2017?

Epidiolex

GW Pharmaceuticals (NASDAQ: GWPH) presented three studies at the American Epilepsy Society’s 69th Annual Meeting in Philadelphia that highlight the safety and effectiveness of its cannabidiol-based drug, Epidiolex. Some analysts predict FDA approval as early as 2017.

If approved, Epidiolex might offer another treatment option for parents of children with treatment-resistant forms of epilepsy, such as Lennox-Gastaut Syndrome and Dravet Syndrome. The larger political implications Big Pharma’s entrance into the world of medical cannabis are somewhat more mixed, however.

Since its founding in 1998, GW Pharma has focused on discovering, developing and commercializing therapeutic drugs from specially-bred cannabis plants. Its high-THC drug, Sativex, used in the treatment of muscle spasms associated with multiple sclerosis, has been approved for use in 28 countries and fast-tracked for FDA approval in the United States.

Epidiolex, a high-CBD drug was approved for an expanded access Investigational New Drug program. Of the 261 patients who were the subjects of the most recent studies, nearly half saw a reduction in total seizures of greater than or equal to 50 percent after 12 weeks of treatment. GW has announced that it expects to have results from larger Phase 3 safety and efficacy studies during the first half of 2016.

GW Pharma has long positioned itself as a regular pharmaceutical company that coincidentally uses compounds derived from the cannabis plant. It has opposed full legalization because of the potential for negative impact on its share price, even going so far as to hire a high-profile marijuana critic to help it distinguish its products from medical marijuana. The profitability of drugs like Epidiolex and Sativex depends, quite directly, on the continued federal barriers to medical marijuana research in this country as well as the continued illegality of cannabis use under federal law.

Nowhere was the competition for dollars more obvious than in the decision by the Florida Department of Health to use its earmarked CBD research funds to test Epidiolex rather than raw CBD oils like Charlotte’s Web.

Epidiolex may offer an alternative for parents uncomfortable with breaking the law. But decisions to direct research funds to the product of an international pharmaceutical company rather than to a more home-grown remedy may keep drug prices high for the parents of desperately-ill children.

On the other hand, it could also be argued that FDA-approval of plant-based drugs, unlike the synthetic THC drug Marinol, which has been on the market since 1985, may finally make the argument that cannabis should be classified as a Schedule I drug untenable. Schedule I drugs are those with a high potential for abuse and no legitimate medical use. FDA approval of Sativex or Epidiolex would be tacit recognition that a legitimate use exists. In an ironic twist of fate, GW Pharma’s success could be Epidiolex’s undoing.

GW Pharma is reportedly ramping up production of Epidiolex in anticipation of FDA approval and the significant commercial demand for the drug that would follow. The implications for patients and the further fallout for the medical marijuana industry may begin to emerge shortly thereafter.

Anne Wallace is a New York lawyer who writes extensively on legal and business issues. She also teaches law and business writing at the college and professional level. Anne graduated from Fordham Law School and Wellesley College.

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