GW Pharmaceuticals Announces That Sativex Receives Fast Track Designation From FDA in Cancer Pain
"The award of Fast Track designation for Sativex represents important recognition by the
GW is developing Sativex in
About Sativex in Cancer Pain
Sativex is an investigational product composed primarily of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol), administered as a metered dose oromucosal spray. Cancer pain represents the initial target indication for Sativex in the U.S. and Sativex is currently in a Phase 3 program for the treatment of advanced cancer pain with initial data expected around the end of 2014. It is estimated that pain is uncontrolled with opioid treatments in approximately 420,000 people in
In addition to the development of Sativex in cancer pain, Sativex is currently approved in 25 countries (primarily in
About the Agreement Between GW and Otsuka
In
About
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 25 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
Forward-looking statements
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic and commercial value of the company's compounds including Sativex® and Epidiolex®, the development and commercialization of Sativex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval. 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®, Epidiolex®, 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
CONTACT: Enquiries:Source:GW Pharmaceuticals plc (Today) + 44 20 7831 3113Justin Gover , Chief Executive Officer (Thereafter) + 44 1980 557000Stephen Schultz , VP Investor Relations (US) 401 500 6570 FTI Consulting (Media Enquiries)Ben Atwell /Simon Conway /John Dineen (UK ) + 44 20 3727 1000 Robert Stanislaro (US) 212 850 5657Trout Group, LLC (US investor relations)Todd James /Chad Rubin 646 378 2900
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