Orexo AB announced today that it has received approval from the U.S. Food and Drug Administration (FDA) of two higher dosage strengths of Zubsolv (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. The new dosage strengths are 8.6 mg/2.1 mg and 11.4 mg/2.9 mg buprenorphine/naloxone CIII sublingual tablets. The 8.6 mg/2.1 mg dosage strength is expected to be launched early 2015 and the 11.4 mg/2.9 mg strength later in 2015.

The new dosage strengths complement the existing strengths of 5.7 mg/1.4 mg and 1.4 mg/0.36 mg tablets and enable patients to receive their optimal dose in one tablet. The new strengths are made with the advanced, proprietary sublingual tablet formulation in Zubsolv providing higher bioavailability, a fast dissolve time, small tablet size, and menthol flavor.

For more details, go to: http://www.orexo.com/en/Investor-Relations/Press-releases/?guid=959626