Newron Pharmaceuticals Completes Enrolment of Clinical Phase II Study with Ralfinamide in Post-Surgical Dental Pain
The study, a phase II, pilot, randomised, placebo-controlled, double-blind, parallel-group, multi-centre study, was designed to determine the safety, tolerability and preliminary evidence of preventive analgesic efficacy of orally administered ralfinamide at a dose range of 320/480 mg per day, compared to placebo, in patients with third molar, post-extraction, dental pain. The study was performed in 15 study centres in India and Romania.
202 patients were screened and 187 randomised (1:1) to ralfinamide or placebo. Patients received 5 days of pre-treatment with ralfinamide at 320 mg/day or placebo prior to the day of molar-extraction surgery. On the day of surgery, patients received a total daily dose of ralfinamide at 480 mg or placebo. On the two days following surgery, patients received treatment at 320 mg/day of ralfinamide or placebo.
The trial design was based on a pre-clinical study that demonstrated that pre and/or post-operative treatment with ralfinamide provides long-lasting suppression of spontaneous post-surgical neuropathic pain-related behaviour. 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.
About Newron Pharmaceuticals
Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Newron is undertaking phase III trials with safinamide for the treatment of Parkinson’s disease (PD) in conjunction with its partner, Merck Serono, which has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, Alzheimer´s disease, and other therapeutic applications. Newron is conducting phase II trials with ralfinamide for the treatment of neuropathic and post surgical (dental) pain. A phase II placebo controlled study in patients with peripheral neuropathic pain demonstrated the efficacy of ralfinamide in reducing the severity of pain, as well as demonstrating an improvement in sleep and the ability to perform daily activities. The drug was well tolerated, with no change in the incidence of adverse events compared to placebo.
On February 9, 2008, Newron signed an agreement providing for the acquisition of 100% of the issued share capital of Hunter-Fleming, a private UK bio-pharmaceutical company developing new medicines to treat neurodegenerative and inflammatory disorders. The transaction enlarges Newron's pipeline particularly in the area of neuro-inflammation. Hunter-Fleming provides a pipeline of three compounds in various phases of clinical development and one in discovery. The most advanced compound is in an ongoing phase II safety and tolerability study in Alzheimers’ disease patients. The agreement is conditional to shareholders’ approval, expected for April.
Newron’s clinical pipeline is supported by a portfolio of early-stage proprietary compounds generated by its ion channel drug discovery platform. Newron is headquartered in Bresso, near, Milan, Italy. The company is listed at SWX Swiss Exchange, trading symbol NWRN.