GW Pharmaceuticals this morning said it has filed for approval of its cannabinoid medicine Sativex (tetrahydrocannabinol plus cannabidiol) to relieve spasticity in people with multiple sclerosis in some European markets.
The UK firm has decided to seek approval of Sativex under the European Union’s decentralized procedure, whereby the UK will act as reference member state for a green light in Spain, Denmark and the Netherlands. Once approved, Sativex will be marketed in the UK by Bayer HealthCare and in the rest of Europe by Spain’s Almirall.
Dr Stephen Wright, GW’s R&D Director, said: “Taking into account the views of the regulators, as well as the unmet needs of this target patient group...this body of data warrants serious regulatory evaluation.”
Last year, the firm faced a setback after losing an appeal to conduct another clinical trial in MS-related pain to satisfy the demands of UK regulators. GW had originally hoped to get Sativex onto the market there before the end of 2003, but has seen a string of delays, as well as concerns over the drug’s safety after an inquest linked it to the death of a patient who took part in trials.
Meanwhile, the company is ploughing on with developing Sativex in other late-stage trials, including in neuropathic pain in MS and peripheral neuropathy.