Dec. 2, 2013
/PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that it engaged in a positive meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical development program for Clonidine Topical Gel that will allow the program to proceed to Phase 3 clinical studies in the first quarter of 2014.
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 (PDN). The FDA agreed with the overall clinical program proposed by BDSI which included two placebo-controlled studies and one safety study in patients suffering from painful diabetic neuropathy, the duration of treatment required for the safety assessment, and the plan for data integration from prior and planned clinical studies.
"As we continue our work to expand and diversify our product pipeline, we are very pleased with the outcome of our discussion with FDA regarding the development program for Clonidine Topical Gel," said Dr.
, Executive Vice President of Product Development. "The discussion has provided us with the input and clarity needed to progress the program directly to Phase 3, and we will initiate the first of two pivotal studies in early 2014. It also appears that the FDA recognizes the need for new treatment options for painful diabetic neuropathy by confirming Fast Track designation for the program that could potentially lead to a priority review."
The feedback from FDA enables BDSI to initiate the first of two placebo controlled studies in early 2014. If the initial placebo controlled study meets its primary endpoint, the results for which could be available as early as the end of 2014, BDSI could be in a position to initiate the second placebo controlled study in 2015 with an NDA projected for 2016.
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 commonly the feet. Patients with PDN often experience debilitating pain symptoms that affect day-to-day functioning and quality of life.