BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy. 

The Phase 3 trial is a multicenter, randomized, double blind, placebo controlled study to determine the efficacy and safety of 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.

"We are very pleased to be moving another important clinical program into Phase 3 development," said Dr. Andrew Finn, Executive Vice President of Product Development.  "There is a significant unmet need for new treatment options for patients suffering from painful diabetic neuropathy, and we look forward to progressing enrollment forward and toward anticipated interim results during the fourth quarter of this year followed by final study results in the first quarter of 2015."

"BDSI plans to conduct an independent interim analysis based on 50% of the patients completed," said Adrian Hepner, MD, Vice President of Clinical Research.  "We anticipate that results of the interim analysis will be available in the fourth quarter of this year, and if the results confirm current study assumptions, the second Phase 3 trial of similar size and scope will be initiated at that time.  This timeline could allow for a 2016 NDA submission."

BDSI met with representatives of the FDA on November 21, 2013 to discuss the proposed clinical development program for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (also known as PDN).  The FDA agreed with the overall clinical program proposed by BDSI, which includes two well controlled studies and one long-term safety study in patients suffering from painful diabetic neuropathy, the duration of treatment required for the safety assessment, the plan for data integration from prior and planned clinical studies and the interim analysis of the first pivotal trial.  FDA also confirmed Fast Track designation for the program which recognizes the need of developing new therapies for this serious condition.