Newron initiates Ph II ralfinamide trial

Milan, Italy-based Newron Pharmaceuticals SpA has initiated a Phase II study with its drug candidate ralfinamide in post-surgical dental pain. The pilot, randomized, placebo-controlled, double-blind, parallel-group, multicenter study, is designed to determine the safety, tolerability and preliminary evidence of preventive analgesic efficacy of orally-administered ralfinamide at a target dose of 480mg/day, compared to placebo, in patients with third molar, post-extraction, dental pain. It is being conducted in India and Romania.

Approximately 180 patients will be randomized to receive the maximum daily dose of ralfinamide or placebo. They will receive five days of pre-treatment with study medication prior to the day of the molar-extraction surgery, and will be treated on the day of surgery and for two days thereafter.

The trial follows a recently-performed study which demonstrated that pre- and/or post-operative treatment with ralfinamide provides long-lasting suppression of spontaneous post-surgical neuropathic pain-related behavior, in a rat model of hindpaw neurectomy. It is believed that the analgesic and anti-inflammatory effects of ralfinamide are mediated through its modulation of ion channels implicated in pain, inhibition of substance P and glutamate release.