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Orexo presents data from a Phase 3 clinical trial that demonstrates that Zubsolv is as effective as Suboxone film in the treatment of opioid dependence


Wednesday, 25 Jun 2014 02:30am EDT 

Orexo AB:Announces top-line data from a Phase 3 clinical trial demonstrating that Zubsolv (buprenorphine/naloxone CIII sublingual tablet) is as effective as Suboxone film in the treatment of opioid dependence.The results from a randomized, non-inferiority, multicenter, comparative trial (N=758) establish that, despite a 29 pct lower dose, Zubsolv provides equivalent efficacy compared to Suboxone film in patients who are opioid dependent.The primary endpoint of the ISTART study was retention in treatment at Day 15 with Zubsolv and Suboxone film.The study showed that there was no difference in retention in treatment at Day 15 [Zubsolv arm: 83pct (273/329); Suboxone film arm: 82.5pct (269/326)].As previously announced an additional co-primary endpoint assessed Zubsolv as a treatment for induction of buprenorphine maintenance therapy compared to generic buprenorphine monotherapy.There was no difference in retention at Day 3 [Zubsolv arm: 93.3pct (309/329); generic buprenorphine arm: 92.6pct (302/326)] in the per protocol set.Similar improvements for both groups were observed in Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), and opioid cravings VAS total scores.Physicians and patients, using the Clinical Global Impression (CGI-I) and Patient Global Impression (PGI-I) Improvement scales, reported that both treatments resulted in an average score of much improved from baseline at study end. 

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