BioDelivery Sciences International to add 80 patients to clinical trial of Clonidine Topical Gel

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

Suggested Articles

Researchers in the U.K. have developed a technique to better predict results in liver cancer when drug-laden polymer beads are used to deliver medicines.

Researchers at Johns Hopkins have changed the structure of a new cancer drug to allow it to more easily pass the blood-brain barrier, giving it access to…

Medtronic’s world-first FDA-approved hybrid closed-loop insulin delivery system might soon face competition, as T1D Exchange has pledged to invest in the…