BioDelivery Sciences International ($BDSI) announced today that it will add about 80 patients to its Phase III pivotal trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy. "We are encouraged by the outcome of the interim analysis," said Dr. Andrew Finn, executive vice president of product development at BDSI, in a statement. "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." Release