GW Pharmaceuticals plc (NASDAQ:GWPH) has pushed the legalization of cannabis ahead with its work on the drug Epidiolex. Now the company is making its plans for its other cannabis drug Sativex known and it’s impressive and hopeful.
The company is announcing its plans for its pipeline product nabiximols to the U.S. market. This strategy includes multiple opportunities for the submission of an initial New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), the earliest of which could occur in 2021.
“We are excited to present the details of our clinical program and regulatory strategy for nabiximols, which we believe support the potential for a substantial near-term commercial opportunity in the U.S. Following constructive meetings with the FDA, we are now commencing a Phase 3 clinical program that provides multiple opportunities for an NDA submission, including as early as 2021”, stated Justin Gover, GW’s Chief Executive Officer. “Beyond the initial target indication of MS spasticity, our Phase 3 clinical program is designed to achieve a broad spasticity label over time. This development strategy, together with the long-term exclusivity potential of nabiximols, provides GW with confidence that this product should represent a significant value driver for GW.”
What Is Nabiximols?
According to GW Pharma, Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. The product is administered as a mouth spray. The commercial name outside the U.S. is Sativex and it is commercially available for the treatment of MS spasticity in numerous countries.
The biotech company outlined the following plans for Sativex:
MS Spasticity Clinical program
- Three positive Phase 3 MS spasticity trials already completed outside of the U.S.
- Five new MS Spasticity Phase 3 trials are expected to commence in H2 2020 (2) and H1 2021 (3), any one of which we believe could enable a NDA submission
- Phase 3 muscle tone studies – placebo-controlled cross-over design
- N=52; Expected start: Q4 2020
- N=190; Expected start: Q1 2021
- N=36 (nabiximols responders); Expected start: Q1 2021
- Phase 3 spasm frequency studies – placebo-controlled parallel group
- N=450; Expected start: Q4 2020
- N=~200 (nabiximols responders); Expected start: Q2 2021
Spinal Cord Injury (SCI) spasticity clinical program
- Three SCI trials are expected to be initiated in 2020 and 2021
- N=~100 (observational clinical discovery study); Expected start: Q4 2020
- N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021
- N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021
This second spasticity indication may lead to broad anti-spasticity labeling and usage.
Post Traumatic Stress Disorder (PTSD) clinical program
- We are also exploring the potential of nabiximols to reduce sleep disturbance symptoms, as well as anxiety and irritability, in patients with PTSD
- A Phase 2/3 study in PTSD will have approximately 325 subjects and is anticipated to be initiated in H1 2021
GW Pharmaceuticals stock has moved higher over the past six months. The stock hit a low of $72 in March and was recently trading at $121. It looks to be moving higher based on the news for Sativex.