Benzinga | Apr 13, 2021 08:37AM EDT

GW Pharmaceuticals And US Subsidiary Greenwich Biosciences To Present Data At 2021 American Academy Of Neurology Annual Meeting Apr. 17-22

GW Pharmaceuticals plc (NASDAQ:GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, announced today that the company will present results from completed trials of EPIDIOLEX(r) (cannabidiol) oral solution and nabiximols, known as Sativex(r) outside of the U.S., at the virtual American Academy of Neurology (AAN) Annual Meeting taking place April 17-22. The company will also present findings of a survey in partnership with the North American Research Committee on Multiple Sclerosis (NARCOMS) -- the world's largest voluntary, patient-driven multiple sclerosis (MS) registry -- highlighting the prevalence of cannabis use among people with MS. Additionally, the company will share an update on cannabis-based products, including the evidence-based pathway to FDA approval and related regulatory challenges.

"AAN provides us with an opportunity to continue sharing the safety and efficacy data of EPIDIOLEX in the treatment of tuberous sclerosis complex and other treatment-resistant forms of epilepsy," said Justin Gover, Chief Executive Officer, GW Pharmaceuticals. "We will also highlight the potential value of nabiximols for people living with spasticity associated with multiple sclerosis as we continue to advance the product in clinical trials with a view to seeking U.S. regulatory approval. We are committed to building the body of evidence which proves cannabinoid medicines can be well characterized and meet the highest standards for FDA approval -- rigorously studied and consistently manufactured -- so that neurologists can feel confident prescribing them to those in need."

2021 AAN presentations will include:

All posters will be available in the Virtual Poster Hall for the duration of AAN.

EPIDIOLEX Posters:

* P7.016: Efficacy and Safety of Cannabidiol (CBD) in Patients with Treatment-Resistant Epilepsies (TREs) in the Expanded Access Program (EAP): Additional Efficacy Data for Convulsive and Nonconvulsive Seizure Types -- Lyons et al.

* P7.025: Long-term Efficacy and Safety of Cannabidiol (CBD) in Patients with Tuberous Sclerosis Complex (TSC): 4-year Results from the Expanded Access Program (EAP) -- Weinstock et al.

* P7.004: Efficacy of Add-on Cannabidiol (CBD) Treatment in Patients with Tuberous Sclerosis Complex (TSC) and a History of Infantile Spasms (IS): Post Hoc Analysis of Phase 3 Trial GWPCARE6 -- Sparagana et al.

* P7.002: Long-term Safety and Efficacy of Add-on Cannabidiol (CBD) for Treatment of Seizures Associated with Tuberous Sclerosis Complex (TSC) in an Open-Label Extension (OLE) Trial (GWPCARE6) -- Wheless et al.

Nabiximols Posters:

* P15.115: Prevalence of Cannabis Use and Associated Factors Among People with Multiple Sclerosis (PwMS): A 2020 NARCOMS Survey -- Salter et al.

* P15.181: Study of nabiximols in persons with multiple sclerosis (PwMS) with inadequately managed spasticity: post hoc analyses of a controlled enrichment design study -- Ben-Zacharia et al.

* P15.185: Effect of nabiximols cannabinoid oral-mucosal spray on depressive symptoms, suicidality, and cognition in persons with multiple sclerosis (PwMS) -- DeLuca et al.

Additional company activities (accessible in the AAN Virtual Exhibit Hall):

* EPIDIOLEX Virtual Booth

* Cannabinoid Clinical Virtual Booth

* Industry Therapeutic Update, a discussion exploring the evidence-based pathway to FDA approval and the regulatory challenges facing cannabis-based products (April 19, 2021 at 7 p.m. ET)