The director of the neurology residency training program at the Icahn School of Medicine at Mount Sinai addresses the challenges of approving cannabinoid products in the US.
“[Nabiximols] has been approved outside the US for around 10 years. But we've never had it here... it's an entire modality of treatment, a cannabinoid derivative that we have not been able to utilize for MS spasticity and symptom management in the United States.”
GW Pharmaceuticals has initiated a phase 3 clinical trial studying nabiximols for the treatment of multiple sclerosis (MS)-associated spasticity. Nabiximols is a cannabidiol (CBD)-based oral spray marketed as Sativex outside of the US where it is approved for use in over 25 countries. It contains both CBD and tetrahydrocannabinol, as well as other botanical components.
The trial will assess for a decrease in spasm events in patients with MS in the US, in accordance with beneficial results seen in international studies. The drug could potentially fill the void of approved cannabinoid products to treat MS symptoms amidst the growing popularity of using (and studying) unapproved cannabinoid products.
NeurologyLive reached out to Stephen Krieger, MD, associate professor of neurology and director, neurology residency training program, Icahn School of Medicine at Mount Sinai, who serves as an investigator for the phase 3 trial to learn more about the challenges of getting nabiximols and other cannabinoids approved in the US versus other countries. Krieger also discusses the potential of cannabinoid-based therapies and the importance of establishing quantifiable and clinical meaningful outcomes in the study.