GW Pharmaceuticals Presents Nabiximols U.S. Development and Commercial Strategy
- Potential accelerated pathway to NDA submission -
CARLSBAD, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announces the Company’s strategy for bringing 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. GW will host a webcast today to provide insight into the U.S. Phase 3 clinical program and commercial opportunity for nabiximols.
“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.”
Highlights of GW’s nabiximols U.S. clinical development strategy:
Spinal Cord Injury (SCI) spasticity clinical program
This second spasticity indication may lead to broad anti-spasticity labeling and usage.
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.
Nabiximols is known as Sativex® outside of the United States and is commercially available for the treatment of MS spasticity in numerous countries. These approvals were based on multiple pivotal trials conducted in Europe1.
1: Markova et al, International Journal of Neuroscience 2019; Novotna et al, European Journal of Neurology 2011; Collin et al, European Journal of Neurology 2007
About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.
Millimeter Wave: The Need for Speed
Privacy for IoT
Get Your Factories Connected -- Fast!