Avanir's Neurodex sees strong Ph III data

The USA's Avanir Pharmaceuticals says that strong data were reported on Neurodex, its drug candidate for involuntary emotional expression disorder, also known as pseudobulbar affect and emotional lability, from a pivotal Phase III clinical trial.

The data, published in the May issue of the Annals of Neurology, demonstrate the safety and efficacy of Neurodex, an orally administered combination of dextromethorphan and low-dose quinidine, in the treatment of IEED patients with multiple sclerosis.

The double-blind Phase III clinical study was completed in June 2004 and saw 150 patients at 22 clinical sites randomized to receive either placebo or Neurodex on a 12-hour dosing schedule for 85 days. A minimum CNS-LS score of greater than or equal to 13 was required for inclusion in the study. For the primary endpoint, patients receiving the agent had a significantly greater reduction in CNS-LS score than those given placebo (p<0.0001).