In a letter to senators, the Drug Enforcement Administration said that they plan to decide whether marijuana should be reclassified under federal law in the first half of 2016.
The letter was sent in response to a letter from Democratic Senator Elizabeth Warren (Massachusetts) and sever other Democratic Senators in 2015. In the letter, the senators urged the government to facilitate research into the medical benefits associated with marijuana.
According to the letter, the Food and Drug Administration (FDA) reviewed the medical evidence surrounding the safety and effectiveness of marijuana and forwarded its rescheduling recommendation to the DEA. The document didn’t reveal what the FDA recommended.
Follows Favorable Clinical Trials
This development comes less than a month after GW Pharmaceuticals plc (GWPH) announced positive results for the first Phase 3 Clinical study for its Epidiolex product.
In the study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo. Epidiolex has both Orphan Drug Designation and Fast Track Designation from the FDA.
Patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39% compared with a reduction on placebo of 13%, which was highly statistically significant. A series of sensitivity analyses of the primary endpoint confirmed the robustness of this result. The difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period.
Marijuana support has grown significantly over the last two years and the United States is reaching a tipping point.
For the first time ever, a few well-respected surveys show that a majority of Americans favor the legalization of cannabis. Also, approximately 80% of voters want to see U.S policy recognize the “drug” as what it really is: a medicine.