June, 29, 2010-- Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. announced top-line results from a Phase II placebo and positive comparator-controlled, parallel-arm, double-blind, dose-response clinical trial of the novel, investigational NR2B-selective NMDA (N-methyl D-aspartate) receptor antagonist, radiprodil (RGH-896), for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPNP). Treatment with radiprodil did not show statistically significant or clinically meaningful reductions in mean daily pain scores, the primary endpoint, compared to placebo for any of the dosages studied.The companies will review the complete study database over the coming weeks to determine the appropriate next steps regarding the development of radiprodil.
About the Study
This was a randomized placebo and active-controlled parallel-arm, double-blind, dose-response study in patients with diabetic peripheral neuropathic pain (DPNP) who were clinically diagnosed with painful polyneuropathy (greater-than or equal to 6 months) due to type I or type II diabetes mellitus. Patients had a minimum daily pain rating of at least four at screening, and an average daily pain rating of at least four (on an eleven-point scale) during the one week before baseline.
Following a five-week screening/washout period during which all analgesic medications used for DPNP were discontinued, a total of 458 male or female outpatients between 18 and 75 years of age were randomized to one of three radiprodil doses (15mg, 30mg, 45mg), an active comparator (100mg pregabalin), or placebo given three times a day (TID) for 14 weeks... Forest Laboratories' Press Release -
