Nabiximols Phase 3 Trial: Investigating Cannabinoids for MS Spasticity


Stephen Krieger, MD from the Icahn School of Medicine at Mount Sinai spoke about the phase 3 trial of nabiximols he will be investigating in MS.

Stephen Krieger, MD, associate professor of neurology and director, neurology residency training program, Icahn School of Medicine at Mount Sinai

Stephen Krieger, MD

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.

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 Nabixinols as a treatment option for MS, and the challenges of getting cannabinoids approved in the US. 

NeurologyLive: What challenges do you face trying to get nabiximols approved in the US versus other countries? And how does the trial design and the desired outcomes differ in the US to address that?

Stephen Krieger, MD: Well, Nabiximols is a cannabinoid derivative, a medication that has been used and approved for treatment of multiple sclerosis (MS) spasticity in countries outside the United States. This was based on studies that were performed, looking at efficacy in MS spasticity. And based on successful trials, this has been approved outside the US for around 10 years, but we've never had it here. And so, 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. So, I think it's a great thing that we're now moving forward with phase three trials, to look at Nabiximols for spasticity in multiple sclerosis in a way that has a regulatory pathway for approval in the US. You know, the FDA is very particular about how all medicine is studied for approval, but in particular, schedule one type agents or, in this case, a cannabinoid derivative. So, it was really important that in designing these trials, they were done with objective outcomes that would be ascertainable in a study and also clinically meaningful for patients. Spasticity itself can take different forms for patients, there can be sort of chronic ongoing stiffness, and contracture. There can also be episodic spasms, which can often be very uncomfortable, even painful, for people with MS. The trials that are being done now and the one that I'm working on, are going to look at nabiximols’s ability in preventing these episodic spasms, which is a quantifiable outcome. I think that's something that will be favorable by the FDA if it's successful. This is also a clinically meaningful outcome—something that we can look at, and see patients report if they are having a decrease in numbers of these spasm events. And that would be I think, a powerful, powerful indicator of advocacy if it's successful.

Does nabiximols offer any unique advantages with treating MS, as a cannabinoid derivative?

Well, MS spasticity is 1 of many symptoms that MS can cause that can affect and decrease quality of life. We've made huge strides in our ability to treat MS in a preventative way. There's been an explosion of disease modifying therapies (DMTs) for MS in the past 10 or so years. That's based on really well-done trials with meaningful endpoints and good outcomes, and we just don't have that in treating MS spasticity—we don't have great data on treatments, we certainly don't have recent data. I often say that we're very data driven when it comes to MS preventative treatment, but when it comes to MS symptom management, we're very improvisational, we don't have a lot of rigorous data to work from. I think having a rigorously designed trial and good outcomes for individuals will give us something more to work with than we've had before. From the perspective of how it works, you know, we have pills and other things that can help with spasticity to some degree, but they often have a lot of systemic side effects. It can be very sedating. And so, I think having a different modality of treatment to approach MS spasticity will open up a new avenue to treat it. There's been a lot of interest in cannabinoids, in a variety of ways. From a mechanism perspective, I think people will be interested to see whether it can be beneficial for them.

Transcript edited for clarity.

GW Pharmaceuticals initiates pivotal phase 3 study of nabiximols for multiple sclerosis-associated spasticity. News release. GW Pharmaceuticals. November 3, 2020. Accessed November 16, 2020.
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