GW welcomes MHRA's Sativex statement

Drug developer GW Pharmaceuticals has welcomed the UK Medicines and Healthcare products Regulatory Agency's (MHRA) announcement that there are no preclinical issues preventing the approval of the cannabinoid-based drug Sativex for multiple sclerosis-related spasticity. The agency said that the firm had satisfactorily addressed all of the key pharmaceutical points raised by its review.

The MHRA statement will be seen as generally positive for the Salisbury-headquartered firm, which withdrew a Marketing Authorization Application seeking European Medicines Agency (EMEA) approval for Sativex in MS spasticity on concerns that its submission would not meet efficacy requirements (Marketletter July 30). However, the agency also said that one efficacy issue remained, specifically, that the firm needs to confirm the results of post hoc analysis that "non responders can be identified in a four week therapeutic trial, and that the mean treatment effect in the remaining patients who would continue to receive treatment, would be clinically significant."

In response, GW's chairman, Geoffrey Guy, said that the efficacy "issue, detailed in the report, is being addressed through an additional Phase III clinical trial, which commenced recently."