Clonidine, a topical gel designed for the treatment of painful diabetic neuropathy, will begin phase three studies early in 2014 after its maker, North Carolina-based BioDelivery Sciences International, Inc., garnered fast-track approval from the Food and Drug Administration for the trials.
As it continues to assess the effectiveness and safety of the drug, BDSI will include two placebo-controlled studies along with one study on the safety of the drug for those suffering from diabetic neuropathy in its upcoming research.
“As we continue our work to expand and diversify our product pipeline, we are very pleased with the outcome of our discussion with FDA regarding the development program for Clonidine Topical Gel,” said Dr. Andrew Finn, Executive Vice President of Product Development at BDSI, said that the FDA had granted Fast Track designation for the drug, an indicator “that the FDA recognizes the need for new treatment options for diabetic neuropathy that could potentially lead to a priority review.”
BDSI met with representatives of the FDA on Nov. 21 to discuss the proposed Phase 3 clinical process. If the results of the first placebo-controlled studies are as expected, the company could initiate second studies in 2015, allowing the gel to reach the marketplace by 2016.
Clonidine gel is believed to relieve the pain of diabetic peripheral neuropathy-an often debilitating side effect of diabetes that can severely impact quality of life for sufferers-by decreasing the abnormal hyper-excitability of nerve cells, slowing the cells’ response to pain stimuli.
It works differently than the oral medications currently on the market used to treat neuropathy, and would be the only topical product approved for the treatment of this painful condition.
Many of the nearly 26 million people in the U.S. who have diabetes, according to the American Diabetes Association, suffer from neuropathy, which creates tingling, burning, or stabbing pains in the feet, a result of damaged nerves.
BDSI estimates the annual sales potential of Clonidine to be in excess of $300 million.