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Orexo AB announces positive top-line results from two phase 3 clinical trials that Assessed Zubsolv for induction of Buprenorphine Maintenance Therapy

Monday, 23 Jun 2014 02:32am EDT 

Orexo AB:Announces 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 pct of patients treated with Zubsolv were retained in treatment at Day 3 using a 30 pct lower dose of buprenorphine.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 pct 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.An analysis of the combined data from the ISTART and OX219-007 studies found no difference when comparing Zubsolv and generic buprenorphine monotherapy when used as treatment for the induction of buprenorphine maintenance therapy.In the combined per protocol set, 92.3 pct (422/457) of patients in the Zubsolv group were retained in treatment at Day 3 compared to 93.4 pct (424/454) of patients receiving generic buprenorphine (p=0.54).Similar results were observed in the combined full analysis set where 90.9 pct (489/538) of patients in the Zubsolv group were retained at Day 3 compared to 92.6 pct (491/530) generic buprenorphine group (p=0.30). 

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