ZUBSOLV® for Opioid Dependence: Trial Results Reported

Erik Gunderson, M.D., FASAM Assistant Professor Department of Psychiatry and Neurobehavioral Sciences and Department of Medicine University of Virginia Principal Investigator of the studyMedicalResearch.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.

Medical Research: What should clinicians and patients take away from your report?

Response: This is the largest clinical trial conducted in the United States to assess buprenorphine/naloxone for the treatment of opioid dependence. The data indicate that ZUBSOLV can be safely and efficaciously initiated during the treatment of opioid dependence. Despite an average 26-32 percent lower buprenorphine dose with ZUBSOLV during the trial, ZUBSOLV treatment demonstrated comparable efficacy with generic buprenorphine during induction and with Suboxone film during early stabilization.

Medical Research: What recommendations do you have for future research as a result of this study?

Response: It is important we remain committed to clinical research in advancing and testing medication-assisted treatments for opioid dependence. These study results reinforce the importance of continued research in the potential for ZUBSOLV as a treatment option for induction and stabilization. Future research should examine the safety and efficacy over a longer term.

Citation:

AAAP ISTART Abstract Presented at 25th Annual Meeting and Symposium of the American Academy of Addiction Psychiatry (AAAP) in Aventura, Florida, USA.

Summary:

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.

The full press release can be found here. This is the largest clinical trial ever conducted in the United States to assess buprenorphine/naloxone for the treatment of opioid dependence.

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