BioDelivery: First Patient Enrolled In Clonidine Topical Gel Phase 3 Study

(RTTNews) - BioDelivery Sciences International Inc. (BDSI) announced 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.

"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," said Andrew Finn, Executive Vice President of Product Development.

The company stated that it 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.