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Swedish Company Submits NDA for Zubsolv (OX219) for Treatment of Opioid Dependence

Drug would be first alternative to Suboxone (Sept. 6)

Orexo, based in Uppsala, Sweden, announced on September 6 that it has submitted a New Drug Application (NDA) to the FDA for a combination product consisting of buprenorphine and naloxone for the treatment of opioid dependence, a condition that affects more than 2 million Americans.

If approved, Zubsolv (OX219) would be the first alternative treatment option to Suboxone (Reckitt Benckhiser), which also consists of buprenorphine and naloxone. The new drug is formulated for sublingual administration.

A company spokesman said that the NDA submission allows a potential launch of Zubsolv in the third quarter of 2013. In clinical studies, Zubsolv had a smaller tablet size, a faster dissolve time, and an improved taste compared with Suboxone.

The U.S. market potential for Zubsolv is estimated to be $500 million in annual sales.

For more information, visit the Orexo Web site.

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