GW Pharmaceuticals plc a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to Sativex® for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.
Sativex is currently in Phase 3 clinical trials for this indication. FDA’s Fast Track program facilitates the development of drugs intended to treat serious or life threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. “The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain,” stated Justin Gover, GW’s Chief Executive Officer. “Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications. We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn.” GW is developing Sativex in the United States in collaboration with Otsuka Pharmaceutical Co. Ltd.
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 Sativexin 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 the United States.
In addition to the development of Sativex in cancer pain, Sativexis currently approved in 25 countries (primarily in Europe) for spasticity due to Multiple Sclerosis.
About the Agreement Between GW and Otsuka
In February 2007, GW and Otsuka entered into an exclusive license agreement to develop and market Sativex in the U.S. Under the terms of this agreement, the costs of pre-clinical and clinical development activities required for U.S. approval are to be wholly funded by Otsuka, and Otsuka hold exclusive rights to commercialize Sativex in the U.S.