BioDelivery Sciences invested a mix of stock and cash that could total nearly $40 million if a proposed gel to treat diabetic neuropathy pain wins FDA approval, and the company says it will proceed with further tests after a “positive” meeting with regulators.
In April, Raleigh-based BDSI (Nasdaq: BDSI) struck the licensing deal with privately held Arcion Therapeutics for the gel known as ARC4558 or Clonidine Topical Gel.
On Monday, BDSI said it met with FDA regulators on Nov. 21. As a result of that meeting, BDSI plans Phase 3 clinical trials in the first quarter of next year.
“The FDA agreed with the overall clinical program proposed by BDSI which included two placebo-controlled studies and one safety study in patients suffering from painful diabetic neuropathy, the duration of treatment required for the safety assessment, and the plan for data integration from prior and planned clinical studies,” the company said in a statement.
BDSI paid $2 million up front in stock for development and commercializing rights to the gel known as ARC4558. Arcion also would receive royalties on sales.
Some 26 million people suffer from diabetes in the U.S.
Other stock and cash payments will be made as the drug advances toward FDA approval. The gel is in Phase 2 clinical trial and has received “fast track” status from the FDA.
BDSI envisions the market for the treatment as being up to $300 million a year.
As a topical gel, the treatment is expected to avoid systemic side effects, BDSI said.
“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. “The discussion has provided us with the input and clarity needed to progress the program directly to Phase 3, and we will initiate the first of two pivotal studies in early 2014. It also appears that the FDA recognizes the need for new treatment options for painful diabetic neuropathy by confirming Fast Track designation for the program that could potentially lead to a priority review.”
Based on results of the first placebo-controlled studies and if the primary endpoint is met, a second similar study could be launched in 2015 followed by a “New Drug Application” in 2016.
