Medmonitor

The White House issued an Executive Order that orders the Attorney General to take all necessary steps to complete the rulemaking process related to rescheduling marijuana to Schedule III of the Controlled Substances Act in the most expeditious manner in accordance with Federal law. While the rulemaking process will still take time to unfold, with many legal challenges and speed bumps to expect along the way, this action makes it clear that the DEA has been given direct priority to reschedule marijuana.  Marijuana’s current status as a Schedule I drug creates many roadblocks for clinical research, but this change will allow for greater clinical research, which could further shape the landscape of medical marijuana. First and foremost, drug developers would face fewer hurdles in creating medications derived from marijuana, which could result in FDA-approved medications. Additionally, an increase in clinical research could lead to greater insights that could better shape marijuana policies and therapies.

A randomized, controlled Phase 3 clinical trial compared VER-01, an experimental cannabis-derived drug, with opioids in 384 patients with chronic low-back pain. VER-01 was found to be superior to opioids in terms of pain reduction over 6 months of treatment. Throughout the 6 months of treatment, mean pain reduction using an 11-point numeric rating scale (NRS) was 2.50 NRS points with VER-01 versus 2.16 with opioids. These benefits were particularly pronounced in participants with severe pain, with greater pain reduction and sleep improvement compared to opioids. Furthermore, patients receiving VER-01 were four times less likely to develop constipation.

The DEA announced plans to reschedule marijuana from a Schedule I drug to a Schedule III drug. Rescheduling marijuana would not make it legal for recreational use, as Schedule III drugs are still controlled substances and subject to rules and regulations. However, this proposal recognizes the medical uses of cannabis and acknowledges that cannabis has less potential for abuse than other drugs. Clinical research has found that marijuana has the potential to assist with the treatment of chronic pain, neuropathic pain, spasticity, PTSD, depression, and anxiety. Much opposition to the use of medical marijuana in workers’ comp has been tied to federal restrictions, which will soon be lifted; this could result in greater utilization of medical marijuana. The DEA’s proposal will first be reviewed by the White House Office of Management and Budget. Once the White House signs off on the proposal, the DEA will hold a 60-day public comment period, after which it will be reviewed by an administrative judge. After this, the DEA would publish the final rule.