Orexo AB Release: Positive Top-Line Results From Two Phase 3 Clinical Trials That Assessed Zubsolv® For Induction Of Buprenorphine Maintenance Therapy

Uppsala, Sweden – June 23, 2014 – Orexo AB (publ) announces the results of two clinical trials assessing Zubsolv for induction of buprenorphine maintenance therapy in patients with opioid dependence. Combined data from the Induction, STabilization, Adherence and Retention Trial (ISTART) (Study OX219-006) and Study OX219-007, in 1068 opioid dependent patients, showed that over 90% of patients treated with Zubsolv were retained in treatment at Day 3 using a 30% lower dose of buprenorphine. The two studies had similar structure during the three-day induction phase to enable a combined analysis of the induction results, with the ISTART being the most important contributing with 70% of the patients. These results enable Orexo to pursue a regulatory submission of an expanded label of Zubsolv to include initiation of treatment in the US.

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