GW Pharmaceutical Gets Closer To Forcing FDA On Cannabis

GW Pharmaceutical Gets Closer To Forcing FDA On Cannabis

Debra Borchardt , CONTRIBUTOR
I write about the business of marijuana.

Opinions expressed by Forbes Contributors are their own.
British biotech company GW Pharmaceuticals announced positive results on its latest Phase 3 clinical trial for its drug Epidiolex. The drug is cannabidiol-based and is used to treat children with Lennox-Gastaut syndrome, a rare form of childhood epilepsy.
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GW Pharmaceuticals cannabis plant.

The results from the test were very positive. Patients taking 20mg of Epidiolex saw their seizures on average drop 42% compared to a drop of 17% in patients taking a placebo. Patients taking 10mg of Epidiolex experienced a 37% drop in seizures versus the 17% drop in the placebo group.

The next step for GW Pharmaceuticals is to seek approval from the U.S. Food and Drug Administration or FDA for approval. The company said it expects to submit a New Drug Application with the FDA in the first half of 2017. If approved, it would be the first plant-derived cannabinoid drug in the U.S. to be approved. After the FDA approves a new drug application, the Drug Enforcement Administration (DEA) legally must reschedule within 90 days (per the Improving Regulatory Transparency for New Medical Therapies Act). So, Epidiolex would be rescheduled by DEA within 90 days, but overall marijuana would not be rescheduled.

GW Pharmaceuticals is quick to point out that Epidiolex is not marijuana. Epidiolex is an oral pharmaceutical formulation of cannabidiol, one of many cannabinoids found in the cannabis sativa plant. CBD is a non-psychoactive component of the cannabis plant.GW Pharmaceuticals does not want its product to be confused with medical marijuana.

Having said that, this further complicates the rescheduling argument. How could the DEA declare Epidiolex, cannabinoid drug a medicine, but then still insist marijuana has no medicinal benefits? Of course, they do that now because the U.S. government has medical patents on marijuana and still declare it has no medicinal qualities.

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