BioDelivery Sciences updates on topical clonidine gel phase 3 for the treatment PDN

BioDelivery Sciences updates on topical clonidine gel phase 3 for the treatment PDN -

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced today that she completed a pre-specified interim analysis of the first pivotal phase 3 trial for clonidine current topical gel for the treatment of painful diabetic neuropathy (PDN).

interim analysis was performed on data the first 50% of patients who completed the study. The purpose of the interim analysis was to allow an adjustment of the sample size necessary to maintain the appropriate statistical power to detect a treatment effect between clonidine and placebo topical gel.

ISDB views the result of the analysis as very encouraging. Following the interim analysis, a total of approximately 80 additional patients will be added to the current test in an effort to maintain 0% of the power percent to detect a statistically significant difference between gel and topical clonidine placebo. The analysis was performed by an independent biostatistician.

"We are encouraged by the results of the interim analysis," said Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. "The more patients not only allow us to maintain the probability finally meet the assessment criteria of the study, but given that the registration of the initial study was about three months ahead, we still expect the first results by the end of the first quarter of 2015. Furthermore, the size of the expanded sample will provide a sufficient number of subjects to complete the long-term safety study required that will be part of our NDA package. Also part of the NDA will be a second pivotal trial that we expect from early 2015. "

" the results of the interim analysis is important because it used the actual study data make an adjustment of the sample size to maintain the probability of a positive outcome, "said Dr. Mark A. Sirgo, President and CEO." based on this information, we will continue to progress other aspects of the clinical development program required for NDA. "