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Positive FDA Meeting Confirms BDSI Phase 3 Program for Clonidine Topical Gel for Treatment of Painful Diabetic Neuropathy
Date:12/2/2013

RALEIGH, N.C., 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.

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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. Andrew Finn, 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 stud
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SOURCE BioDelivery Sciences International, Inc.
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