BioDelivery Sciences gets good news from FDA

Posted by David Bracken on December 2, 2013 

BioDelivery Sciences International announced Monday that it expects to begin Phase 3 clinical trials for its drug Clonidine by the first quarter of next year.

The Raleigh company said in a statement that it had a positive meeting with Food and Drug Administration officials on Nov. 21 about the development of Clonidine, a gel to treat painful diabetic neuropathy, a condition that afflicts some people suffering from diabetes.

Regulators agreed with BioDelivery’s program for the studies. The feedback means the company can move ahead with the first of two controlled studies early next year.

In March, BioDelivery Sciences reached a licensing deal with Arcion Therapeutics to develop Clonidine. Under the terms of the agreement, BioDelivery will make an upfront payment of $2 million in the form of shares of BDSI common stock to Arcion.

Arcion will receive an additional $2.5 million in stock after the FDA accepts a new drug application for the gel and between $17.5 million and $35 million if the application is approved.

The deal also includes sales milestones and royalties on global sales that are in the low single-digits.

BioDelivery said that it could submit a new drug application for Clonidine in 2016. The company has previously said a substantial number of the nearly 26 million people in the U.S. with diabetes also have neuropathy, a condition that results in pain in the extremities, most often in a patient’s feet.

BioDelivery has one drug on the market and in August submitted a new drug application for Bunavail, a treatment for people who are dependent on opioids. The company reported last month that it expects to hear back from the FDA on its drug application for Bunavail on June 7. The company also expects to have results from its initial Phase 3 clinical trial of BEMA Buprenorphine, the company’s experimental treatment for chronic pain, by early next year.

BioDelivery shares closed Monday at $4.95, up 15 cents. The stock is up nearly 15 percent this year.

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