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.
|Indication||Opioid use disorder|
|Commercial rights||Orexo commercializes ZUBSOLV® in the US, but owns the rights worldwide except for Australia and New Zealand where Mundipharma Pty Ltd. will start to commercialize ZUBSOLV® early in 2020.|
|Partner||Orexo is seeking partners for ZUBSOLV® in other markets ex-US, Australia and New Zealand.|
|Patent protection||In all major markets until 2032|
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. The broad choice of six different strengths offers the potential for finer titration and individualized dosing with potentially fewer tablets compared with existing substitution treatments.
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. In November 2017 the EU-commission approved ZUBSOLV® for treatment of opioid dependence in Europe and in beginning of 2019 it was also approved in Australia.
ZUBSOLV® should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of certified physicians.