Sativex nabiximols: Phase IV data
Top-line data from a double-blind Phase IV trial in 121 patients with spasticity due to MS showed that there was a "slight improvement" in cognitive function as measured by total PASAT score from baseline to 12 months, the primary endpoint, in both the Sativex and placebo arms, which GW said confirms that there is no evidence of long-term cognitive impairment in patients taking Sativex compared to placebo. Additionally, the company said the change in mood as measured by BDI-II scores was "more or less identical" in both treatment arms. On secondary endpoints, Sativex significantly improved Global Impression of Change scores as assessed by the patient (p<0.0001), physician (p=0.001) and caregiver (p=0.004) vs. placebo. GW said the trial was required as a post-approval commitment by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). Data will be presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Copenhagen in October. ...