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Zubsolv (Buprenorphine/Naloxone) Accepted for FDA Review

Approval decision expected in July 2013 (Nov. 19)

The FDA has agreed to review the New Drug Application (NDA) for Zubsolv (buprenorphine and naloxone, Orexo). The agency has set a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2013.

Zubsolv is a sublingual formulation of the semi-synthetic opioid buprenorphine and the opioid inverse agonist naloxone. If approved, the drug is expected to be launched in September 2013. It has been designed to offer an alternative to Suboxone (buprenorphine and naloxone, Reckitt Benckiser) — currently the leading product in the U.S. for the treatment of opioid dependence.

More than 2 million Americans are dependent on opioids, with related healthcare costs totaling an estimated $25 billion. The U.S. opioid dependence market currently served by Suboxone is estimated to reach sales of $1.5 billion in 2012 and to show steady growth of more than 15% per year thereafter.

Source: Orexo; November 19, 2012.

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