Three doses of Forest Laboratories' experimental pain drug radiprodil failed to register a significant improvement over a placebo for reducing the level of pain among diabetic patients in a Phase II trial. And Forest along with its partner, Hungary's Gedeon Richter, will go back to the drawing board and see where the program should go from here.
A total of 458 diabetic men and women were recruited for the study and given doses of radiprodil (RGH-896) ranging from 15 mg to 45 mg. But researchers failed to detect a statistically significant response for either the primary or secondary endpoint of reduced pain scores when compared to a placebo. The companies released top-line data only.
"The companies will review the complete study database over the coming weeks to determine the appropriate next steps regarding the development of radiprodil," the developers said in a release. Radiprodil has been in development for a broad range of neuropathic pain conditions, including diabetes.
- check out the Forest release for more info