BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that the primary efficacy endpoint in the Phase 3 clinical study of Clonidine Topical Gel compared to placebo for the treatment of painful diabetic neuropathy did not meet statistical significance, although certain secondary endpoints showed statistically significant improvement over placebo. In addition, a strong safety profile for the product was observed. The results of this trial provide data that will allow the company to better refine the protocol criteria to capture a more "enriched" patient population and target site selection.
"Based on the results of our previously announced positive interim analysis, this outcome was unexpected," said Dr. Andrew Finn, Executive Vice President of Product Development. "The interim analysis data showed a difference compared to placebo of -0.94 with a standard deviation of 2.2 which was close to our study assumption of -1.0 and 1.8, respectively, and very similar to the prior Phase 2 study conducted by our licensor Arcion."
Dr. Finn continued, "Based on the interim analysis, we added approximately 80 patients to the study. However, this added cohort of patients performed very differently than those assessed in the interim analysis, which lead to our outcome. Going forward, we are confident that the data from this study will provide us with the necessary information to enhance patient entry criteria, patient recruitment, and site selection."
"We believe the results of this trial continue to support that Clonidine Topical Gel is a potentially effective treatment for painful diabetic neuropathy and an important advance in treatment," stated Dr. Mark A. Sirgo, President and Chief Executive Officer. "We encountered similar challenges in our early clinical development work with BEMA Buprenorphine for chronic pain and were ultimately successful in conducting two pivotal studies that met their endpoints. Leveraging this experience and the aspects of this study that we believe are encouraging, we are optimistic that we can achieve a similar outcome with Clonidine Topical Gel."
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