CARLSBAD, Calif., Sept. 10, 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, along with U.S. subsidiary Greenwich Biosciences, will present results of a survey conducted in partnership with the North American Research Committee on Multiple Sclerosis (NARCOMS) -- the world’s largest voluntary, patient-driven MS registry1 -- highlighting the prevalence of cannabis use among people with MS. The survey found nearly one-third of U.S.-based participants had tried THC-containing cannabis for their MS symptoms at least once, with 20 percent reporting cannabis use within the past 30 days.
The survey results will be presented at MSVirtual2020, the joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The NARCOMS Survey abstract (P0439) can be found here. The data will be made available virtually at 9:00 AM EST on Friday, September 11, 2020.
“The use of unapproved, unregulated, THC-containing cannabis by people with MS underscores that these patients’ needs are not being met by existing approved medicines and reinforces the need for a new FDA-regulated option,” said Justin Gover, GW’s Chief Executive Officer. “We continue to advance the clinical development of cannabinoid therapies that meet the rigor of FDA review with the goal of delivering an approved THC-containing treatment to the MS community in the future.”
The NARCOMS survey, which included more than 3,000 people with MS, found that over 60 percent of respondents reported experiencing spasticity, pain, or sleep problems. Of those surveyed, 1,012 respondents (31 percent) indicated they had used THC-containing cannabis for their MS symptoms at least once: 51 percent reported using cannabis to treat spasticity, 44 percent to treat pain, and 38 percent to support sleep. There were 636 (20 percent) respondents who reported current use of cannabis for their MS, while 376 (11.6 percent) reported prior use.
“Spasticity, pain and sleep issues significantly impact the daily lives and quality of life of people living with MS,” said Dr. Amber Salter, Assistant Professor of Biostatistics at Washington University School of Medicine. “Our data demonstrate that many people have tried cannabis products to manage symptoms, supporting the need for research in this area.”
About the Cannabis Use Among People with MS: A 2020 NARCOMS Survey
The objective of the 2020 NARCOMS survey was to evaluate the contemporary prevalence of cannabis use among persons with MS, and demographic factors associated with cannabis use for MS symptom management. The online survey results included 3,249 respondents, the majority of whom were female (78.5 percent) and Caucasian (88.5 percent). Respondents had an average age of 61 years and median disability level using Patient Determined Disease Steps (PDDS) scale of 3 (Gait Disability), with the 25th to 75th percentile ranging from 1 (Mild Disability) to 6 (Bilaterial Support). The average age of respondents at the onset of MS symptoms was 31 years.
The NARCOMS Global Patient Registry uses the power of patient experience to improve clinical care and quality of life for persons with multiple sclerosis and their families by developing collaboration among centers of excellence and researchers in MS throughout the world. NARCOMS’ focus is on creating and maintaining a database of individuals’ experience with MS and making that information available, to researchers in the MS community.
About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company is also carrying out a Phase 3 trial in Rett syndrome and has a deep pipeline of additional cannabinoid product candidates, including nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.
Nabiximols is expected to enter pivotal Phase 3 development in the United States in the second half of 2020. The U.S. commercial rights are owned by GW. GW anticipates developing multiple indications for nabiximols with an initial target indication for the treatment of MS spasticity, to be followed by Spinal Cord Injury spasticity and Post Traumatic Stress Disorder, or PTSD.
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 an oral spray.
Nabiximols is known as Sativex® outside of the United States and is indicated in numerous countries as a treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.2 These approvals were based on multiple pivotal trials conducted in Europe.3 Sativex is currently not approved for any indication in the U.S.
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1 ClinicalTrials.gov, NARCOMS Registry: A Multiple Sclerosis Registry https://clinicaltrials.gov/ct2/show/NCT01018537 Accessed August 22, 2020.
2 Sativex Oralmucosal Spray, SmPC, https://www.medicines.org.uk/emc/product/602.
3 Markova et al, International Journal of Neuroscience 2019; Novotna et al, European Journal of Neurology 2011; Collin et al, European Journal of Neurology 2007About Nabiximols