The associate professor of neurology at the Icahn School of Medicine at Mount Sinai discussed how he and colleagues are assessing nabiximols in hopes of adding it to the short list of approved THC agents.
“THC containing products are much more tightly regulated. The FDA has a much stricter set of guidance about what it takes to have proof of efficacy and safety. There are very few approved products that involve THC or synthetic versions of that, so this would be new in FDA approved treatments, especially in multiple sclerosis.”
GW Pharmaceuticals has initiated a phase 3 clinical trial studying nabiximols for the treatment of multiple sclerosis (MS)-associated spasticity. Nabiximols is an oral spray marketed as Sativex outside of the US, where it is approved for use in over 25 countries. Unlike GW’s other cannabinoid drug Epidiolex, Nabiximols consists of both cannabidiol (CBD) and tetrahydrocannabinol (THC).
In an interview with NeurologyLive, Stephen Krieger, MD, associate professor of neurology, Icahn School of Medicine, Mount Sinai, where he also serves as director of the neurology residency training program, discusses the growing popularity of regulated and unregulated cannabis products as treatment for MS.
Very few cannabinoid therapies have been approved in the US. Krieger, who serves as an investigator for the phase 3 trial, comments on the stricter guidelines for medicines that contain THC when compared to other trials for which he has served as investigator. He also believes there will be strong patient interest in the drug and encourages doctors to refer patients to the study.