Newron completes in enrollment in Ph II trial of rafinamide in neuropathic pain

Milan, Italy-based Newron Pharmaceuticals SpA has completed enrollment in a Phase II, double-blind, randomized, placebo-controlled, international study of ralfinamide. 259 patients with moderate-to-severe neuropathic pain have been recruited in this eight-week trial.

According to the firm, ralfinamide is a unique New Chemical Entity that combines use- and frequency-dependent inhibition of sodium channels present on sensory neurons and blockade of calcium ion flow, believed to be implicated in the pathogenesis of neuropathic pain.

Newron's chief medical officer, Ravi Anand, noted that the study includes various sub-types of neuropathic pain patients and, using multiple assessment measures, should determine the type of neuropathic pain that is most responsive to ralfinamide, while determining the dose range of the drug that will be evaluated in future efficacy and safety trials. The company is on schedule to announce the results of this safety, tolerability, and preliminary evidence of efficacy trial by end of June 2007, he added.