Newron kicks off phase II ralfinamide study

Newron Pharmaceuticals has announced that it is to commence a phase II study using ralfinamide in post-surgical dental pain.

The study is intended to investigate the safety and tolerability of preventative analgesic efficacy of orally administered ralfinamide at a target dose of 480mg/day when used in the treatment of patients with third molar post-extraction dental pain.

With trials taking place in India and Romania, around 180 patients will receive a maximum daily dose of 480mg/day of ralfinamide or a placebo.

Each patient will receive five days of pre-treatment then given ralfinamide prior to the day of extraction surgery, on the day and two days after.

Ravi Anand, Newron?s chief marketing officer, outlined: “The demonstration of analgesic and anti-inflammatory activity in this trial would indicate that ralfinamide could be developed for other post surgical pain and have potential for efficacy in other inflammatory pain conditions.”

The trial follows a recent study showing that pre and/or post treatment with ralfinamide reduces spontaneous post-surgical neuropathic pain-related behaviour in a rat model of hindpaw neurectomy.

Last year Serono announced a deal with the Italian research and development company Newron to acquire the worldwide rights to safinamide, a new drug for the treatment of cognitive disorders.