Orexo gets US FDA approval for opioid dependence drug Zubsolv

4 July 2013

Swedish drug developer Orexo (STO: ORX) today (July 4) received approval from the US Food and Drug Administration for Zubsolv (buprenorphine/naloxone) sublingual tablet CIII, for use as maintenance treatment for people suffering from opioid dependence.

The company said it expects the product, which will become the first competitor to Reckitt Benckiser’s Suboxone (buprenorphine and naloxone sublingual tablets), to bring in sales of at least $500 million a year. Orexo's shares rose 11.7% to 73.75 kronor in mid-morning trading on the news.

Zubsolv is a once-daily under-the-tongue tablet that dissolves within minutes. Orexo said that compared with other buprenorphine/naloxone treatments, Zubsolv has higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste. Zubsolv will be launched in September in the USA by Orexo US and its partner Publicis Touchpoint Solutions.

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