It looks like BioDelivery Sciences ($BDSI) is on its way to a Phase III clinical trial of its topical gel treatment for painful diabetic neuropathy following a "positive" meeting with the FDA.
The topical gel delivers the drug Clonidine, which stimulates a receptor subtype associated with the pain receptors in the skin, Al Medwar, vice president of marketing and corporate development, told FierceDrugDelivery. By lowering the excitability of these pain receptors, it has shown to reduce local pain, which is associated with the diabetes-related neuropathy, and which affects nearly 26 million people in the U.S., according to the company.
Currently there are several oral treatments on the market, but there are no approved topical treatments for the disease, although the trial is not aimed at comparing the topical gel to these options.
"A number of oral medications are approved for the treatment of PDN and neuropathic pain, such as Lyrica and Cymbalta, with sales of products to treat neuropathic pain totaling over $3 billion in the U.S.," Medwar wrote in an email. "… There is a significant unmet need for new treatments since existing oral options have limited efficacy and systemic side effects."
After the FDA meeting, during which the agency agreed with the proposed clinical program moving forward, BioDelivery expects to push the candidate into two pivotal studies in early 2014. The FDA also confirmed Fast Track designation for the program, which could lead to a priority review, according to the company.
"Articles suggest patients can realistically expect a 30% to 50% reduction in discomfort with available products at their maximal doses," Medwar said. "We believe clonidine offers an alternative treatment that can be used either alone or to augment oral treatments."
Painful diabetic neuropathy, or PDN, is characterized by impaired sensation and pain in the extremities, mostly in the feet, in diabetics. In March, BioDelivery Sciences secured the rights to the clonidine gel from Arcion Therapeutics.
- here's the release