Forest Laboratories’ investigational drug for treating neuropathic pain associated with diabetic peripheral neuropathy has failed to meet the primary endpoint of its Phase II trial.
Radiprodil (RGH-896) did not demonstrate clinically meaningful reductions in mean daily pain scores compared to a placebo for any dosage studied.
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The trial involved 458 adults with diabetic peripheral neuropathy, who were randomised to one of three radiprodil doses (15mg, 30mg or 45mg), an active comparator or a placebo, three times a day for 14 weeks.
The most common adverse events after treatment with radiprodil were dizziness, fatigue and insomnia.
Radiprodil is an orally active NR2B (a sub-unit of the NMDA receptor) antagonist discovered by Gedeon Richter, who are co-developing the drug with Forest Laboratories.
The two companies will review the study again to plan the next steps in development.
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