DECEMBER 7, 2020
Entering Exclusive License and Supply Agreement with Accord Healthcare for ZUBSOLV® in Europe
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 use disorder (OUD). ZUBSOLV® should be used as part of a comprehensive treatment plan, which includes counselling and psychosocial support. |
| Market approvals | US, EU and Australia |
| Commercial rights | Orexo commercializes ZUBSOLV® in the US. Accord Healthcare owns the rights to 29 European countries and launch will be initiated in H2 2021. Rights to other markets are owned by Orexo. |
| Partner |  |
| 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.
The REZOLV study (Retrospective Evalutation of Zubsolv Outcomes - A Longitudinal View). Completed August, 2016
Overall the study was a success, with 978 of the 1,080 patients in total confirmed as being evaluable for treatment efficacy. From the patients evaluable for treatment, 77.6 percent (n=759) were determined to have been a treatment success, defined as a patient who completed 28 days of treatment and tested negative for opiates on the last follow-up drug screen.
To enable physicians and payers to define the optimal treatment plan of each patient treated with Zubsolv, the REZOLV study offers the largest existing clinical database. The data from the REZOLV study can assist in identifying and rationalizing some of the important factors associated with successful treatment of opioid dependence. Amongst such factors identified, the REZOLV study indicated that positive treatment outcome was related to:
- Patients who were older (>50 years, n=101) had a treatment success of 88.1 percent compared 73.8 percent of patients aged 20-30 years
- Patients who had support of a spouse or a partner (n=315) had a higher treatment success of 83.5 percent, compared to 75.2 percent for patients without a partner
- Patients who were employed (n=534) showed a higher rate of treatment success compared to those who were unemployed (n=444), with rates of 81.5 percent and 73,0 percent, respectively
- Patients who were abusing heroin (n=358) had a treatment success of 69.6 percent and patients injecting opioids (n=235) showed a treatment success of 65.5 percent, indicating an increased risk of treatment failure
- Previous history of failed treatment (n=460) had a negative impact on the treatment success with 72.2 percent succeeding compared to 84.7 percent of patients with Zubsolv® as their first treatment (n=458)
- Treatment success was not impacted by the experience of the physicians or whether they were Board certified in addiction treatment.
The study results have generated an extensive amount of clinical data that Orexo will use in its dialogues with key stakeholders, including physicians, prescribers, politicians and payers, on how to advance the treatment of opioid dependence. The completion of the REZOLV study further strengthens Orexo’s position as the market player with the most substantial clinical database, as a result of its substantial investments into documenting how treatment of opioid dependence may be optimized.
For more information about clinical trials, please contact Orexo US Inc.
Link to medical guide
Link to prescription information
Patent Information
In accordance with 35 U.S.C. § 287(a), the list below identifies patents that may cover ZUBSOLV® in the US. The list may be non-exhaustive and there may be additional patents pending.
8,470,361
8,658,198
8,940,330
9,259,421
9,439,900
10,874,661
10,946,010