Stephen Krieger, MD

“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).

, 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.

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. 

https://www.globenewswire.com/news-release/2020/11/03/2119212/0/en/GW-Pharmaceuticals-Initiates-Pivotal-Phase-3-Study-of-Nabiximols-for-Multiple-Sclerosis-Associated-Spasticity.html

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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. 

Stephen Krieger, MD: The Challenges of Investigating THC-Containing Agents

“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. Having a different modality of treatment to approach MS spasticity will open up a new avenue to treat it—and there's been a lot of interest in cannabinoids.”

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 consisting of both cannabidiol (CBD) and tetrahydrocannabinol marketed as Sativex outside of the US where it is approved for use in over 25 countries. 

, Stephen Krieger, MD, associate professor of neurology at the Icahn School of Medicine at Mount Sinai where he also serves as director, neurology residency training program, discusses the lack of treatments for MS symptom management and the potential and growing popularity of cannabinoids to fill that gap. 

Krieger, who serves as an investigator for the phase 3 trial, also comments on the lack of recent studies and data on drugs to treat MS spasticity and hopes to see nabiximols provide statistically significant and clinically meaningful data. 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. 

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. https://www.globenewswire.com/news-release/2020/11/03/2119212/0/en/GW-Pharmaceuticals-Initiates-Pivotal-Phase-3-Study-of-Nabiximols-for-Multiple-Sclerosis-Associated-Spasticity.html

The associate professor of neurology at the Icahn School of Medicine at Mount Sinai addresses the need for new treatments for MS spasticity. 

Stephen Krieger, MD: Cannabinoids as a New Treatment for MS Spasticity

“[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.

 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.

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.

Stephen Krieger, MD: Investigating the Benefits of Nabiximols on MS Spasticity

"We're very lucky to have so many effective medicines for treating multiple sclerosis but our decisions now are really made in part on how we can use these medicines as safely as possible."

At the Americans Committee for Treatment and Research for Multiple Sclerosis (ACTRIMS) annual meeting, held in Dallas, Texas, Stephen Krieger, MD, spoke about risk mitigation in multiple sclerosis.

Krieger explained that while the space has several effective medicines available for treatment, a major factor in prescribing comes down to how the medicines can be used as safely as possible. He also elaborated on the fact that while there isn’t a perfect biomarker, the biomarkers that are available for risks helps clinicians maximize the benefit:risk ratio of the medicines for an individual patient.

The multiple sclerosis specialist at the Corinne Goldsmith Dickinson Center for MS at Mount Sinai sat down with 

at the meeting for an interview to speak further on the topic.

The multiple sclerosis specialist at the Corinne Goldsmith Dickinson Center for MS at Mount Sinai spoke about risk mitigation in patients with MS and why it's important to choose medicines in an effective way.

Stephen Krieger, MD

Articles

Stephen Krieger, MD: The Challenges of Investigating THC-Containing Agents

Stephen Krieger, MD: Cannabinoids as a New Treatment for MS Spasticity

Stephen Krieger, MD: Investigating the Benefits of Nabiximols on MS Spasticity

Stephen Krieger, MD: Risk Mitigation in Multiple Sclerosis