FDA clears ralfinamide for clinical study

Milan, Italy-based Newron Pharmaceuticals SpA says that the US Food and Drug Administration has granted approval for a trial of its developmental neuropathic pain treatment ralfinamide. The FDA's decision was based on its review of preclinical and clinical data, submitted as part of the Investigational New Drug application.

Ralfinamide is a potent voltage- and use-dependent ion channel blocker that has shown activity in several animal models of chronic pain. Newron said that, in a previously-completed Phase II pilot study, the compound has demonstrated tolerability up to a maximal dose without the occurrence of any consistent pattern of clinically-relevant changes in vital signs or electrocardiogram readings. The new trial is expected to start before the end of the year.