Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Partnering With Jooble

Advertising

The Latest Pharma Jobs, News and Events

pharmiweb.com today | 28 May 2017

GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Announce Publication of Groundbreaking Study of Epidiolex® (cannabidiol) in The New England Journal of Medicine

GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that The New England Journal of Medicine has published results from a Phase 3 study of Epidiolex® (cannabidiol) in children with Dravet syndrome. Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med 2017; 376;2011-20. Epidiolex, GW’s lead product candidate and the potential first in a new category of anti-epileptic drugs, is a liquid formulation of purified, plant-derived cannabidiol (CBD), a non-psychoactive cannabinoid, which is being studied for the treatment of a number of rare, severe pediatric-onset epilepsy disorders. In the study, Epidiolex significantly reduced monthly convulsive seizure frequency compared to placebo in highly treatment-resistant children when added to existing treatment. Treatment with Epidiolex was generally well tolerated, with a safety profile consistent with prior open label experience....

There are currently no treatments approved by the U.S. Food and Drug Administration (FDA) for Dravet syndrome, a rare form of epilepsy associated with a high mortality rate and significant developmental delays. Results from this study represent the only well-controlled clinical evaluation of a cannabinoid medication for this devastating and drug-resistant condition. The New Drug Application for Epidiolex remains on track for submission to the FDA in the middle of 2017.

"Dravet syndrome is one of the most difficult types of epilepsy to treat and many of the children in this study were experiencing dozens, even hundreds, of seizures per month despite taking multiple concurrent anti-epileptic medications," said Orrin Devinsky, M.D., of NYU Langone Medical Center's Comprehensive Epilepsy Center and lead author of the study. “These results suggest that Epidiolex can provide clinically meaningful benefits and I look forward to the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol available as a treatment option for these patients.”

"The publication of these highly-anticipated positive results represents an important milestone for the Dravet syndrome community in that it provides hope that a new treatment option is within sight for this rare and devastating disease," said Nicole Villas, Scientific Director of the Dravet Syndrome Foundation. "As a foundation dedicated to research and patient assistance, we hope the burden of Dravet syndrome on patients and families is recognized and welcome new, well-researched treatments such as this that might help ease the burden."

show more

Latest Press Releases

show more

Latest Poll

Where are you most likely to apply for a job?

Employer Website 50% 50%
Job Board (niche) 17% 17%
Job Board (general) 17% 17%
Agency Listing 17% 17%
Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.