BioDelivery Sciences International ($BDSI) secured rights from Arcion Therapeutics to commercialize the company's first-of-its-kind topical gel to treat painful diabetic neuropathy.
Painful diabetic neuropathy, or PDN, is characterized by impaired sensation and pain most commonly in the feet, and a "substantial number" of people with diabetes can have symptoms, according to BDSI. The company paid $2 million up front to Arcion, as well as a potential $2.5 million in BDSI stock pending FDA acceptance of an NDA and another $17.5 million to $35 million upon regulatory approval.
Topical clonidine works as an analgesic agent that inhibits receptors in the skin associated with pain fibers to restore normal nerve function, and BDSI's version would be the first of its kind approved by the FDA. The topical gel has passed a Phase II study, and BDSI is preparing for a Phase IIb study later this year.
Previous treatments include oral medications such as Pfizer's ($PFE) anticonvulsant Lyrica, Eli Lilly's ($LLY) antidepressant Cymbalta and Janssen's opioid Nucynta with total sales for neuropathic pain drugs reaching more than $3 billion in the U.S. BDSI hopes to collect about $300 of that market with the new topical delivery.
BDSI specializes in delivery methods for pain management, including the sublingual fentanyl Onsolis.
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