BioDelivery Reports Results Of Phase 3 Trial Of Clonidine Topical Gel

(RTTNews) - BioDelivery Sciences International, Inc. (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. The company reported that a strong safety profile for the product was observed.

The company said the results provide data that will allow it to better refine the protocol criteria to capture a more "enriched" patient population and target 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," said Mark Sirgo, CEO.