Aug. 6, 2014
/PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced today that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN).
The interim analysis was performed on data from the first 50% of patients who completed the study. The purpose of the interim analysis was to allow for a sample size adjustment if necessary to maintain appropriate statistical power to detect a treatment effect between Clonidine Topical Gel and placebo.
BDSI views the outcome of the analysis as very encouraging. As a result of the interim analysis, a total of approximately 80 additional patients will be added to the ongoing trial in an effort to maintain 90% percent power to detect a statistically significant difference between Clonidine Topical Gel and placebo. The analysis was executed by an independent biostatistician.
"We are encouraged by the outcome of the interim analysis," stated Dr.
, Executive Vice President of Product Development at BDSI. "The additional patients not only allow us to maintain the probability of ultimately meeting the study's endpoints, but given that the initial study enrollment was about three months ahead of schedule, we still anticipate having top-line results by the end of the first quarter of 2015. In addition, the expanded sample size will provide an adequate number of subjects to complete the required long-term safety study that will be part of our NDA package. Also part of the NDA will be a second pivotal trial that we anticipate starting in early 2015."
"The outcome of the interim analysis is significant because it utilized actual study data to make a sample size adjustment to maintain the probability of a successful outcome," said Dr.
Mark A. Sirgo
, President and Chief Executive Officer. "Based on this information we will continue to progress other aspects of the clinical development program necessary for the NDA."
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine. BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA
) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.
BDSI's development strategy focuses on utilization of the FDA's 505(b)(2) approval process. This regulatory pathway creates the potential for more timely and efficient approval of new formulations of previously approved therapeutics.