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.

 

Short facts  
Technology Sublingual
Indication Opioid dependence
Commercial rights US, Orexo/ ex-US Mundipharma1
 Partner Mundipharma1
 Patent protection  US and Europe 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-commissioned approved Zubsolv for treatment of opioid dependence in Europe. 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.

1 In December 2018 Orexo regained the ex US rights from Mundipharma and are searching for new partners. The contract terminates April 13, 2019.