Newron Reports Phase II Results for Ralfinamide

July 2, 2007

Italian drug company Newron Pharmaceuticals announced results from a Phase II trial of ralfinamide in patients with neuropathic pain.

The double-blind, randomized, placebo-controlled, multinational study enrolled 272 patients with at least moderate neuropathic pain, Newron said.

In the eight-week trial, patients were randomized to treatment with ralfinamide in a dose range of 80 to 320 mg/day or placebo, the company said.

Overall, 79 patients (ralfinamide 32.8 percent; placebo 22.1 percent) discontinued the study. The reasons for discontinuation included: side effects (24 percent), lack of efficacy (8.9 percent), withdrawal of consent (22.8 percent), study interruption by the sponsor (29.1 percent) and other (15.2 percent), according to the company.

The results indicate that ralfinamide was well-tolerated with no evidence of any statistically significant or clinically relevant pattern of change compared with placebo, the company said.