Milan, Italy – April 16, 2008 - Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, today reports positive results from the detailed analyses of the Phase II trial of ralfinamide in patients with neuropathic pain, as presented at the American Academy of Neurology 60th Annual Meeting in Chicago. Newron also reports results from a pilot Phase II safety and tolerability study of ralfinamide in post-surgical (dental) pain.
Nerve Compression and Entrapment Conditions: Aggregate prevalence of about 12% - no drugs approved for nerve compression or nerve entrapment to date Neuropathic Low Back Pain (associated with nerve compression syndromes): accounts for about 60% of all neuropathic pain diagnoses Significant and clinically relevant improvement in VAS/Likert mean change and responder rates Patient rated Activities of Daily Living Quality of Sleep Future development plans discussed with major health authorities
The double-blind, randomised, placebo-controlled, multi-national study (Austria, Czech Republic, India, Italy, Poland, and UK) was performed in 272 patients with at least moderate pain of neuropathic origin, e.g. Diabetic Neuropathy, Post-herpetic Neuralgia, Post-Surgical Neuralgia, Post-compression Neuralgia, etc., diagnosed in accordance with the diagnostic criteria proposed by the International Association for Study of Pain.
In the 8 week treatment, trial patients were randomised to treatment with ralfinamide (n=177) in a dose range of 80 to 320 mg/day, or placebo (n=95). The primary efficacy measure was the change in patient rated visual analogue scale (VAS) of the severity of pain compared to baseline; secondary efficacy measures included the patient rated Likert Pain Scale (LPS), responder rates for the VAS and the LPS, burning/shooting pain as well as impact of treatment on sleep disruption and daily life activities. Safety and tolerability of treatments were judged by assessment of drop-out rate, side effects, ECG, laboratory changes, eye examinations, blood pressure and pulse.
Study Results
Preliminary results for the overall population as announced in 2007 demonstrated that ralfinamide was well tolerated with no evidence of any statistically significant or clinically relevant pattern of adverse change compared with placebo. In this population, treatment with ralfinamide was associated with clinically relevant and statistically significant benefit compared with placebo as judged by results of analyses of mean change from baseline as well as responder rates on the VAS and LPS.
The trial had been designed to include patients with multiple forms of peripheral neuropathic pain (PNP) conditions to allow analyses to determine if the multiple mechanisms of action of ralfinamide would show a unique benefit in any specific neuropathic pain condition. Review of the trial population indicated that the largest group of patients included was experiencing neuropathic pain due to Nerve Compression/Nerve Entrapment (NCET).
