GW Pharmaceuticals plc announces that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent which protects the use of Sativex as a treatment for cancer pain.
The patent, entitled “Pharmaceutical Compositions for the Treatment of Pain”, provides an exclusivity period until April 2025. The patent specifically covers a method of treating cancer related pain by administering a combination of the cannabinoids cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC), the two principal cannabinoids in Sativex. In addition to this newly granted patent, Sativex is protected by a number of other patents related to different aspects of the product.
Sativex is currently in phase III clinical development as a treatment for cancer pain. Cancer pain represents the lead indication for Sativex in the United States, where the medicine is partnered with Otsuka Pharmaceutical Co. Ltd.
Dr Geoffrey Guy, GW’s chairman, said, “The grant of this US patent covering Sativex as a treatment for cancer pain is part of a broad platform of intellectual property rights which continue to be developed by GW. GW now has 35 patent families as well as other forms of protection such as plant variety rights and proprietary know-how. We believe that this matrix of intellectual property provides GW with a unique position to benefit from the rich promise within the field of cannabinoid therapeutics.”
Sativex is approved in the UK, Spain, Czech Republic, Canada and New Zealand as a treatment of Multiple Sclerosis spasticity.
Cancer pain represents the initial target indication for Sativex in the United States. The phase III cancer pain programme is being performed in conjunction with GW’s licensing partner for Sativex in the US, Otsuka Pharmaceutical Co. Ltd. The programme, which is fully funded by Otsuka, includes two phase III randomised placebo-controlled multi-centre multinational trials as well as a long term extension study. Each phase III trial will include approximately 370 patients and will evaluate the efficacy and safety of Sativex versus placebo over a 5 week treatment period.
Studies suggest that more than one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain. Large surveys indicate that optimal opioid therapy does not yield sufficient relief in a substantial proportion of these patients.
GW researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain.