Navigation Links
GW Pharmaceuticals Announces Results of MS Spasticity Study Confirming Sativex Has No Long-Term Negative Effect on Cognition
Date:8/4/2013

LONDON, Aug. 5, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (NASDAQ: GWPH, AIM: GWP, "GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces top-line results from a 12 month placebo-controlled study of Sativex in patients with spasticity due to Multiple Sclerosis (MS). The study results confirm the reassuring safety profile of Sativex and provide further evidence of long-term efficacy.

The study was a 12 month multicentre, double-blind, randomised parallel group, placebo-controlled study in 121 patients with MS spasticity. The study was required as a post-approval commitment by the UK regulatory authority, the Medicines and Healthcare products Regulatory agency (MHRA), with the primary objective of evaluating whether Sativex may have long term adverse effects on cognitive function or mood. The primary endpoint was the change in cognitive function as assessed by the total Paced Auditory Serial Addition Test (PASAT) score from baseline to end of treatment.  Mood was assessed by the Beck Depression Inventory-II.

There was a slight improvement in the PASAT score from the beginning to the end of the study in both the Sativex and placebo groups, thus confirming that there is no evidence of long-term cognitive impairment in patients taking Sativex compared with those taking placebo.  Similarly, the change in mood over the 12 month period was more or less identical in the Sativex and the placebo group, confirming no untoward effect on mood.

The key efficacy secondary endpoints were the global impression of change scores as assessed by the patient, physician and carer. Each of these endpoints was highly significantly in favour of Sativex (p<0.0001, p=0.001 and p=0.004 respectively).

Detailed data from this study is due to be presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on 2-5 October in Copenhagen, Denmark.

Dr Stephen Wright, GW's R&D Director, said, "We are pleased to report positive and wholly reassuring results from this 12 month placebo-controlled study in patients with MS spasticity. We have now shown that Sativex does not impair cognition either in short-term or in long-term use in well designed, randomised, placebo controlled clinical trials.  These data not only confirm the good tolerability of Sativex in long-term use but also provide further evidence of efficacy consistent with that seen in previous shorter duration clinical trials."

About GW Pharmaceuticals plc

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. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 22 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional cannabinoid product candidates, including two distinct compounds, GWP42004 and GWP42003, in Phase 2 clinical development for Type 2 diabetes and ulcerative colitis, respectively, and at least two additional programs expected to enter Phase 1 and Phase 2 clinical trials in the next 12 months. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the results of clinical trials, the relevance of the results of clinical trials, and the development and regulatory clearance of the GW's products.  Forward-looking statements involve risks and uncertainties.  Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW's filings with the U.S. Securities and Exchange Commission, including the prospectus related to the NASDAQ offering filed by GW with the SEC on May 1, 2013. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.


'/>"/>
SOURCE GW Pharmaceuticals plc
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. GW Pharmaceuticals plc Reports 2013 Third Quarter Financial Results
2. AcelRx Pharmaceuticals to Hold Second Quarter 2013 Financial Results Conference Call and Webcast on August 12, 2013
3. Radiopharmaceuticals Market - Global Industry Analysis, Size, Share, Trends And Forecast, 2012 - 2018
4. OPTIMER PHARMACEUTICALS SHAREHOLDER ALERT: Levi & Korsinsky Investigates Possible Breaches of Fiduciary Duty by Board of Optimer Pharmaceuticals, Inc. in Connection with Sale of Company to Cubist Pharmaceuticals, Inc.
5. Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2013 Financial Results
6. Auxilium Pharmaceuticals, Inc, Announces Second Quarter 2013 Financial Results
7. Cadence Pharmaceuticals Reports Second Quarter 2013 Financial Results
8. Arisaph Pharmaceuticals Awarded Phase I STTR Grant To Develop Small Molecule Immune Modulators
9. Avion Pharmaceuticals, LLC, receives top accolades for trade and marketing achievements at the 11th Annual American Business Awards (The "Stevie Awards")
10. Amerigen Pharmaceuticals Limited today announced it had entered into a collaboration agreement with Forest Laboratories Inc. regarding the development of a number of specialty generic products.
11. Vanda Pharmaceuticals Reports Second Quarter 2013 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... Oct. 10, 2017   West Pharmaceutical Services, Inc. ... for injectable drug administration, today shared the results of ... for improving the intradermal administration of polio vaccines. The ... Summit in May 2017 by Dr. Ondrej Mach ... World Health Organization (WHO), and recently published in the ...
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
(Date:10/2/2017)... , Oct. 2, 2017 The Rebound mobile ... the struggle to reverse the tide of prescription drug addiction. ... regulating their medicine intake and stepping down their dosage in ... to launch in December 2017; the first 100,000 people to ... more at http://www.rebound-solution.com/ ...
Breaking Medicine Technology:
(Date:10/13/2017)... TX (PRWEB) , ... October 13, 2017 , ... ... planning agency serving communities in the greater Dallas, Miami, and Raleigh regions, is ... boy fighting to overcome a rare and deadly chromosome abnormality. , After struggling ...
(Date:10/13/2017)... ... ... The American Board of Family Medicine's (ABFM) Board of Directors has selected Warren ... James C. Puffer upon his retirement. Dr. Newton will serve in the position of ... end of 2018. Upon assuming the role of President and CEO on January 1, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of ... ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership in ... It also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... New York, NY (PRWEB) , ... October 13, 2017 , ... ... most influential people in business to advocate for action towards gender equality at their ... 18,000 views from around the globe, and reached a social audience of over 3 ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a ... has been awarded a contract by the Center for Medicare and Medicaid Services ... accelerate the enterprise use of Agile methodologies in a consistent and high value ...
Breaking Medicine News(10 mins):