GW Pharmaceuticals and Bayer's Canadian subsidiary, Bayer Inc, reported full regulatory approval in Canada for use of the cannabis-derived drug Sativex® as an adjunctive treatment for providing symptomatic relief of spasticity in adult multiple sclerosis patients. The oromucosal spray product was approved earlier this year in the U.K. and Spain for the same indication.
Health Canada has previously granted Notices of Compliance with Conditions (NOC/c) for Sativex both as an adjunctive treatment in the symptomatic relief of neuropathic pain in adult MS patients and for its use as an adjunctive analgesic in advanced cancer patients who derived insufficient relief from the highest tolerated dose of opioid therapy.
GW Pharm says an application has been submitted under the European Mutual Recognition Procedure for approval of Sativex in other selected European member states including France, Germany, and Italy. The drug will be marketed in Europe (except the U.K.) by Almirall.
In the U.S. the initial target indication for Sativex is cancer pain. In March GW Pharm and its U.S. development partner, Otsuka Pharmaceutical, confirmed that preliminary results from Phase IIb trials with Sativex for the cancer pain indication support advancing the drug into Phase III development. End of Phase II meetings with the FDA were being planned to gain endorsement of the proposed Phase III program.
In June GW Pharm and Otsuka penned a three-year extension to their global cannabinoid research collaboration focused on the development of new cannabinoid drugs as therapeutic candidates for CNS disorders and oncology indications.