New Phase III trial of ARC 4558 for Diabetic Neuropathy Pain - BioDelivery Sciences

BioDelivery Sciences International announced the enrollment of the first patient in the RHAPSODY Study, a Phase III multicenter, randomized, double blind, placebo controlled study to determine the efficacy and safety of ARC 4558 (clonidine topical gel) in the treatment of pain associated with painful Diabetic Neuropathy.

The study will be conducted in subjects demonstrating functional skin nociceptors, which is the population of patients that demonstrated a statistically significant difference compared to placebo on the primary efficacy endpoint in a previously conducted Phase 2 study. In the RHAPSODY Study subjects will be randomized to receive either Clonidine Topical Gel or a placebo gel. Approximately 140 adult subjects will be randomized into the study, which includes a double blind treatment phase of 12 weeks. The company expects that this timeline could allow for a 2016 NDA submission.