BioDelivery Services New Neuropathy Treatment

Today's post from bizjournals.com (see link below) gives us a rare glimpse into how new treatments are developed and marketed as well as bringing news of a possible breakthrough in neuropathy treatment. It concerns a topical gel called Clonidine, which if it lives up to its promise may bring significant relief without having to swallow yet more pills. The idea is that it reduces the sensory excitability which characterizes so many neuropathic symptoms and that would be a breakthrough. The problem is that it's not on the market yet and is only at the test stage. Experienced neuropathy sufferers will be raising their eyebrows and shrugging their shoulders already - they've heard it all before, many times but given the amount of money that has already changed hands concerning this gel, it does look promising.

BioDelivery Sciences ahead of schedule in developing neuropathy treatment
Jason deBruyn Staff Writer- Triangle Business Journal May 8, 2014, 

Raleigh drug developer BioDelivery Sciences International says it is ahead of schedule to test a proposed treatment for painful diabetic neuropathy (PDN).

Specifically, BioDelivery (Nasdaq: BDSI) has enrolled 50 percent of the patients entering a study to test the safety and efficacy of a product called Clonidine Topical Gel to treat PDN. That’s important because BioDelivery CEO Mark Sirgo had planned to report interim study results based on the first half of enrollees, which now might happen in the third quarter of this year, earlier than originally expected.

While this was welcome news to the drug developer, it came with caution as well.

"We anticipate this rate of enrollment may not be sustained as the initial backlog of patients subsides; however, if no additional patients are needed following the interim analysis, it is possible that we may have final results prior to first quarter of 2015,” said Andrew Finn, executive vice president of Product Development.

Nearly 26 million people in the U.S. have diabetes according to the American Diabetes Association. A “substantial number” of these people have peripheral neuropathy as manifest by impaired sensation and pain in the extremities, most often the feet, according to BDSI. Patients with PDN often experience debilitating pain symptoms that affect day-to-day functioning and quality of life.

BioDelivery licensed the Clonidine gel from Baltimore-based Arcion Therapeutics in March of 2013. BioDelivery paid $2 million in the form of unregistered shares at that point, and will pay another $2.5 million in unregistered shares if the U.S. Food and Drug Administration accepts a new drug application for the product, and cash payments of between $17.5 million and $35 million depending on if the FDA approves the product and what kind of conditions are placed on the approval. The deal also has sales milestones and low single-digit royalties on worldwide sales.

BDSI hopes to market Clonidine Topical Gel as a way to relieve pain by decreasing the abnormal hyper-excitability of skin nociceptors. Currently available oral treatments are modestly effective in relieving symptoms and are limited by systemic side effects and drug interactions. There are no topical products approved for the treatment of this painful condition.

BDSI shares closed down for the second day Wednesday to $8.96, though still traded near the high end of the 52-week range of $3.86-$10.20. The company has a market cap of $430 million

http://www.bizjournals.com/triangle/blog/2014/05/biodelivery-sciences-ahead-of-schedule-in.html