1. Sativex

Manufacturer: GW Pharmaceuticals (GWPH on NASDAQ)

Sativex oral spray Source: “Medical Marijuana aka Sativex Now Available in UK,” examiner.com, June 19, 2010 Cannabis-Related Properties

Mouth spray whose chemical compound is derived from natural extracts of the cannabis plant. Sativex contains two cannabinoids: THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). Suggested Medical Use

Treatment of neuropathic pain and spasticity in patients with Multiple Sclerosis (MS); Analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain. Approval Status

Approved and launched in the UK on June 21, 2010, making it the first cannabis-based prescription medicine in the world (rescheduled from UK Schedule 1 to Schedule 4 on Apr. 10, 2013). Licensed to Bayer in the UK and to Almirall in Europe. Approved to treat spasticity caused by multiple sclerosis in Spain (July 28, 2010), Canada (Aug. 31, 2010), Czech Republic (Apr. 15, 2011), Denmark (June 8, 2011), Germany (July 4, 2011), Sweden (Dec. 22, 2011), Austria (Feb. 7, 2012), Italy (May 7, 2013), and Switzerland (Nov. 27, 2013). Also approved in Finland, Israel, Norway, and Poland. In the US, Phase III clinical trials started in late 2006 for treatment of pain in cancer patients and were in recruitment in 2013. On Apr. 20, 2011, a US patent was granted for Sativex in cancer pain. As of Apr. 28, 2014, Sativex was still in Phase 3 clinical development to treat pain in cancer patients, and the company expects to see results from the program at the end of 2014. On Apr. 28, 2014, the FDA granted “Fast Track” designation to Sativex for the treatment of pain in patients with advanced cancer. The FDA website says that “Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.” GW Pharmaceuticals worked with US licensing partner Otsuka Pharmaceutical to open a Phase III Investigational New Drug application in the United States to treat spasticity due to Multiple Sclerosis on Aug. 14, 2013. On Jan. 8, 2015, GW Pharmaceuticals announced that in the first of three US Phase 3 trials for treatment of pain in patients with advanced cancer, Sativex “did not meet the primary endpoint of demonstrating a statistically significant difference from placebo.” Two additional Phase 3 trials are in progress in 2015.