Zubsolv is a product for the treatment of opioid dependence. Zubsolv has comparable efficacy and safety as well as the same active components as previously approved buprenorphine/ naloxone sublingual formulations.
In July 2013, Zubsolv was approved for the maintenance treatment of opioid dependence by the US Food and Drug Administration, FDA, and in August 2015 the product also received approval for induction treatment of the same patient population. Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII) should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000 (DATA 2000).
|Commercialization||Orexo US., Mundipharma|
|Market||US, ex US1|
1 In June 30 2016, Mundipharma acquired the rights to commercialize Zubsolv outside of the US. On October 3 2016, a regulatory submission for Zubsolv was filed with the European Medicines Agency (EMA). Approval of Zubsolv for the treatment of opioid dependence in Europe is anticipated by the end of 2017
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