MedicalResearch.com Interview with:
Erik Gunderson, M.D., FASAM
Assistant Professor
Department of Psychiatry and Neurobehavioral Sciences and Department of Medicine University of Virginia
Principal Investigator of the study
Medical Research: What is the background for this study? What are the main findings?
Response: The ISTART/006 study was a randomized, multicenter, non-inferiority Phase 3 clinical trial designed to evaluate the efficacy of ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) compared with generic buprenorphine tablets during induction and with Suboxone® film during stabilization of patients with opioid dependence. The co-primary endpoint was retention in treatment at day 3 (when patients began maintenance therapy with either ZUBSOLV or Suboxone film) and retention in treatment at day 15. 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).
758 patients participated in a two-day blinded induction phase randomized to ZUBSOLV or generic buprenorphine tablets, and on day 3 those taking the generic tablets were switched to Suboxone film for a 20-day open-label stabilization and early maintenance phase. At day 15, ZUBSOLV patients switched to Suboxone film and those taking Suboxone film switched to ZUBSOLV.
Please note ZUBSOLV currently is not indicated for induction treatment. In October 2014, Orexo submitted a sNDA to the FDA for that indication.
We found ZUBSOLV demonstrated comparable patient retention in treatment at days 3 and 15 versus generic buprenorphine and Suboxone film respectively, as well as no increased rate of withdrawal symptoms or opioid cravings versus Suboxone film. The safety profile of ZUBSOLV was similar to that of Suboxone film. (more…)