GW's Cannabis-Derived Sativex Earns FDA Fast Track Status

GW Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has granted Fast Track designation to Sativex. The cannabis-derived drug is under investigation for pain in cancer patients. Currently in Phase III trials, Sativex is being co-developed with Otsuka Pharmaceutical. Fast track status confers certain benefits to the drug’s sponsor, including priority access to FDA officials for the purposes of planning and gaining feedback during the investigational process.

Fast Track also indicates that the drug meets a serious, currently unmet need. As Justin Gover, GW’s CEO, said, “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.”

Sativex

Sativex is already approved in 25 countries for Multiple Sclerosis (MS). GW is investigating the agent for advanced cancer patients whose pain is not adequately controlled with opioid therapy — approximately 420,000 people in the U.S.

Sativex is a plant-derived cannabinoid prescription drug composed of CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol). Patients self-administer the drug via a metered dose oromucosal spray. Sativex is in Phase III trials with initial results due by the end of 2014.

GW and Otsuka Agreement  

In 2007, GW and Otsuka entered into an agreement to develop and market Sativex in the U.S. Otsuka is funding the entire pre-clinical and clinical development process necessary for the U.S. approval of Sativex. In return, Otsuka will have exclusive rights to bring Sativex to market in the U.S. GW Pharmaceuticals will manufacture the drug and will oversee the regulatory activities and clinical development with Otsuka.

GW Partners

GW is partnered with other pharmaceutical companies to develop and market Sativex. Current partners are marketing Sativex for MS patients, but if the drug is approved for cancer pain, these companies are likely to join that effort:

• Novartis Pharma AG markets Sativex in Australia, New Zealand, Asia (excluding Japan, China and Hong Kong), the Middle East (excluding Israel/Palestine), and Africa 
• Almirall S.A. markets Sativex in Europe (excluding the UK)
• Bayer HealthCare AG markets in the UK and Canada
• Ipsen Pharma S.A.S holds the rights to market Sativex in Latin America (excluding Mexico and the Islands of the Caribbean)
• Neopharm Group has rights to market in Israel/Palestine