Stephen Krieger, MD, discusses a new phase 3 trial of nabiximols, which is now recruiting patients with MS.
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 (THC), 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.
Stephen Krieger, MD, associate professor of neurology and director, neurology residency training program, Icahn School of Medicine at Mount Sinai, will serve as an investigator for the phase 3 trial. Krieger believes nabiximols represents a promising new avenue of treatment to help improve quality of life in patients with MS. NeurologyLive reached out to Krieger to learn more about the potential of nabiximols as a treatment option for MS and the initial stages of the study.
Stephen Krieger, MD: I think cannabinoids are interesting because of course, people use medical CBD products like Epidiolex (cannabidiol [CBD]; GW Pharmaceuticals), and also non-prescription cannabinoids, and other CBD products. But THC is widely understood as the component of cannabinoids that can have a central nervous system effect. And so, for that reason, THC containing products are much more tightly regulated, and the FDA has a much stricter set of guidance about what it takes to have proof of efficacy and safety. So, there are very few approved products that involve THC or synthetic THC, and this would be new in FDA approved treatments, especially in multiple sclerosis. Even running the trial is a very controlled circumstance, as this is a tightly scheduled class of agent, and requires layers of training, familiarity, and scrutiny that other trials I've been involved with haven't needed. It’s rigorous, for good reason. If the trials are successful, and this can achieve FDA approval in the United States, then some of the challenges might be in terms of what schedule product this will be, how it will be prescribed, and how we can make sure that it's being done safely. But in that regard, the fact that this product has been available for a decade outside the United States gives me a sense of comfort. There's a track record there. This would be new for us, but not for the world. I think that we could learn a little something from how this has been used outside the US to make sure we're doing it well here.
I'm glad that we're talking about this study. It's something that I would love for neurologists to know about it, as it's going on, as a study, in terms of referring patients to MS centers and other places where the study is ongoing to help us with recruitment. It's always a challenge to recruit for clinical trials; doing so in the midst of an ongoing pandemic adds another layer of challenge. So, the more people are familiar with the fact that nabiximols is being studied in trials in the US, the better. I also think that patients will likely ask about it and that people are interested in this. Healthcare providers and neurologists can direct patients to get information about that, so that if this becomes available, they'll already have an understanding of what it's for and how it can be used safely.
Transcript edited for clarity.