Positive results have been reported after a trial of GW Pharmaceuticals’ cannabinoid drug Sativex for patients with spasticity caused by multiple sclerosis (MS).
The company will use this “evidence of long-term efficacy” in a submission to the European regulator planned for later this year.
The trial included 36 MS patients with spasticity who had been taking Sativex for an average of 3.6 years. It found that the condition worsened when they stopped taking the drug, and there was no evidence of a withdrawal syndrome.
In September 2008, GW reported positive results from a study of Sativex in patients with neuropathic pain due to MS.
The company said : “Taken together, these studies show that the efficacy of Sativex in the treatment of both neuropathic pain and spasticity due to MS is maintained in long-term use.”
Dr Stephen Wright, GW’s director of research and development, said: “I am able to confirm that the pivotal phase III trial in MS spasticity is on track to report results towards the end of Q1 09 and a regulatory submission is targeted for Q2 09.”
Copyright Press Association 2009