BioDelivery Sciences International (BSDI) announced that it engaged in a positive meeting with the US Food and Drug Administration (FDA) regarding the clinical development program for Clonidine topical gel that will allow the program to proceed to Phase III clinical studies in the first quarter of 2014.
BDSI met with representatives of the FDA on 21 November 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.
BSDI product development executive vice president Dr Andrew Finn noted as the company continues its work to expand and diversify its product pipeline, the company is very pleased with the outcome of the discussion with FDA regarding the development program for Clonidine topical gel.
"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," Dr Finn added.
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.
