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BioDelivery’s drug to treat painkiller addiction nears FDA review

September 13, 2012 11:19 am by | 0 Comments

(Reuters) - BioDelivery Sciences International Inc said its drug to treat dependence on opioids met the main goal of a key study that U.S. health regulators had asked for, moving closer to filing an application next year.

The company's shares rose to a three-year high of $6.00 on the Nasdaq on Thursday. The stock, which has risen more than six-fold this year, was up 7 percent at $5.80.

BioDelivery's drug, BEMA Buprenorphine/Naloxone (BNX), showed absorption levels comparable to Subaxone, approved to treat opioid dependence.

The U.S. Food and Drug Administration asked the company in February to conduct the study before filing for marketing approval.

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Opioids are very effective at managing pain, but addiction can lead to serious health hazards.

"In the upcoming months, we will continue to evaluate our strategic options for the commercialization of BNX within and outside the U.S., including internal approaches, partnership or a combination of these," Chief Executive Mark Sirgo said in a statement.

(Reporting by Zeba Siddiqui in Bangalore; Editing by Don Sebastian)

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