June 26, 2014
/PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has completed enrollment of all patients required for its initial Phase 3 study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN).
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 PDN. In the trial, referred to as the RHAPSODY Study, subjects are randomized to receive either Clonidine Topical Gel or a placebo gel. One hundred and forty adult subjects have been randomized into the 12 week double-blind treatment phase of the study. This is the first of two pivotal trials that would be required for submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). FDA has granted Fast Track designation for the program, which recognizes the need of developing new therapies for this serious condition.
"We are very pleased with the rapid progression of this study, which we expect will allow for an independent interim analysis based on 50% of the patients completed during the third quarter of this year – one quarter ahead of schedule," said Dr.
, Executive Vice President of Product Development. "The expeditious enrollment of this study in part illustrates the significant unmet need that exists for new treatment options for patients suffering from painful diabetic neuropathy. Based on the enrollment of this trial, and assuming no additional patients will be required following the interim analysis, we should have top-line study results by the end of the year."
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 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 PDN, 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. BDSI is now rolling over patients from the first Phase 3 trial into the 12-month long-term safety study and anticipates starting the second pivotal study in the first quarter of next year. The overall program is being 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.
About Painful Diabetic Neuropathy and Topical Clonidine Gel
Nearly 26 million people in the U.S. have diabetes according to the American Diabetes Association. A substantial number of these people have peripheral neuropathy as manifest by impaired sensation and pain in the extremities, most often the feet. Patients with PDN often experience debilitating pain symptoms that affect day-to-day functioning and quality of life.