GW Pharma's Sativex disappointing in trials

UK-based GW Pharmaceuticals has announced the results of a Phase III trial of the cannabis-derived drug Sativex in the relief of spasticity in multiple sclerosis patients, one of several such programs taking place across Europe.

The study was a randomized, placebo-controlled, parallel group assessment which enrolled 335 MS sufferers with spasticity. The 14-week trial showed that, while patients in the per protocol population showed a positive and statistically-significant improvement in symptoms, analysis of the Intention To Treat population, which comprised all subjects regardless of protocol compliance, did not reveal a statistically-significant benefit in those using the drug. The company says that the lack of significance in the ITT group was due to a larger-than-expected placebo response rather than a question of Sativex' efficacy.

Mike Barnes, professor of neurological rehabilitation at the University of Newcastle, UK, said that the drug had been assessed in a particularly high-need patient population and that the positive per protocol result confirmed the compound's role in treatment-experienced MS spasticity sufferers.