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news.Orexo has announced 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.
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The results from a randomized, non-inferiority, multicenter, comparative trial (N=758) establish that, despite a 29 % lower dose, Zubsolv provides equivalent efficacy compared to Suboxone film in patients who are opioid dependent.
The Induction, STabilization, Adherence and Retention Trial (ISTART) (Study OX219-006), sponsored by Orexo, was the largest trial ever conducted with buprenorphine (N=758).
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: 83% (273/329); Suboxone film arm: 82.5% (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: 93.3% (309/329); generic buprenorphine arm: 92.6% (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.
"The ISTART study confirms Zubsolv is appropriate and effective for maintenance treatment of patients with opioid dependence," said Erik Gunderson, MD, FASAM, the principle investigator of the study.
"When you consider that Zubsolv with a 29% lower dose has similar efficacy to Suboxone film, a preferred taste, child-resistant packaging, and fast dissolve time, physicians have an important alternative treatment option in the fight against this public health epidemic."