Newron's safinamide shows promise as RLS therapy

Newron Pharmaceuticals SpA of Italy says that results from a single-center Phase II pilot study of its investigational new drug, safinamide, showed a significant improvement in all efficacy parameters investigated in 10 patients with restless legs syndrome. In addition, the agent was well-tolerated and was not associated with any drug-related side effects.

"We found that treatment with safinamide improved RLS symptoms. Sleep architecture was not modified; conversely, sleep fragmentation was positively influenced, as this is often the most distressing aspect of the disorder," noted study director Luigi Ferini Strambi, head of the Sleep Disorders Center, San Raffaele Hospital, Italy. "In spite of the short duration and open nature of the study, these positive results, in particular the outcome of the polysomnografic studies, appear important in reference to the currently-used dopaminergic drugs. On this basis, safinamide deserves further exploration as a novel approach in the treatment of RLS," he added.

According to Luca Benatti, Newron's chief executive, "only two drugs are approved specifically for RLS, and are only available in specific countries, so treatment often involves the off-label use of existing central nervous system therapy. Therefore, there is a great demand for better and more effective medicines for this disturbing disorder."