Orexo US, Inc. (Orexo) announced results from the ISTART/006 study, being presented today at the 25th Annual Meeting and Symposium of the American Academy of Addiction Psychiatry (AAAP) in Aventura, Florida, USA. In the study, ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) demonstrated comparable patient retention in treatment at day 15 versus Suboxone® film. ZUBSOLV also demonstrated no increased rate of withdrawal symptoms or opioid cravings versus Suboxone film at day 15 and day 22. AAAP marks the first time these data are presented in a peer-reviewed forum, following the release of topline results in June 2014.
"We look forward to unveil these findings of the ISTART/006 study – the largest clinical trial ever conducted in the United States to assess buprenorphine/naloxone for the treatment of opioid dependence – reinforcing our dedication to advance research in leveraging medication-assisted treatment for opioid dependence," said Michael Sumner, M.D., Chief Medical Officer, Orexo US, Inc. "Despite an average 26 to 32 percent lower dose of buprenorphine in ZUBSOLV compared to that in Suboxone film used, ZUBSOLV showed comparable efficacy to Suboxone film, which may help reduce the potential for misuse."
ISTART Study Design & Outcomes
The ISTART study was a randomized, multicenter, non-inferiority Phase 3 clinical trial designed to evaluate the efficacy of ZUBSOLV compared with Suboxone film during stabilization of patients with opioid dependence.
758 patients began the maintenance phase of the study with either ZUBSOLV or Suboxone film. At day 15, ZUBSOLV patients switched to Suboxone film and those taking Suboxone film switched to ZUBSOLV.
The co-primary endpoint was retention in treatment at day 15. On day 15, the number of patients who were retained in treatment were similar across the ZUBSOLV and Suboxone film arms (74.9 percent versus 74.4 percent, respectively, P=0.866).
Secondary endpoints included assessment of treatment effects on opioid withdrawal symptoms for ZUBSOLV versus Suboxone film via both the Clinical Opiate Withdrawal Scale (COWS) score and Subjective Opiate Withdrawal Scale (SOWS), and opioid cravings via the visual analogue scale (VAS). Reductions in opioid withdrawals and opioid cravings were comparable between treatment groups.
The safety profile of ZUBSOLV was similar to that of Suboxone film.
"I am pleased to present the data of the ISTART study at AAAP, demonstrating ZUBSOLV is comparable to Suboxone film to treat opioid dependence," said Erik Gunderson, M.D., FASAM, Assistant Professor in the Department of Psychiatry and Neurobehavioral Sciences and Department of Medicine at the University of Virginia, and principle investigator of the study.
Robert DeLuca R.Ph., President of Orexo US, Inc. noted, "The ISTART/006 data and our presentation at AAAP are another example of Orexo's continued commitment to both advancing the treatment of opioid dependence and supporting the patients who suffer from this disease as well as the healthcare professionals who treat them."
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