Orexo has announced that the REZOLV retrospective study (Retrospective Evaluation of Zubsolv Outcomes – A Longitudinal View) has been completed as planned in August. With 1,080 patients, the study is the largest retrospective study completed in the U.S. aimed at optimizing the treatment of opioid dependence.

The opioid epidemic in the U.S. continues to increase, and with recent legislative changes in the U.S. that expand access to treatment, the current annual growth of nearly 9% of patients treated is expected to accelerate significantly. During the past three years, Orexo has identified a substantial lack of real-world clinical outcome data on treatment of opioid dependence with buprenorphine-based treatments such as Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII). REZOLV was undertaken as an opportunity to inform physicians, payers and patients about factors that may positively impact treatment outcomes when using Zubsolv for the treatment of opioid dependence.

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% (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% compared 73.8% 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%, compared to 75.2% 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% and 73.0%, respectively
• Patients who were abusing heroin (n=358) had a treatment success of 69.6% and patients injecting opioids (n=235) showed a treatment success of 65.5%, 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% succeeding compared to 84.7% 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.

“The finalization of the REZOLV study is one more important milestone we have reached during the summer. In June we signed an ex-U.S. license agreement with Mundipharma, followed by new legislation in the US with the potential to significantly improve access to treatment with Zubsolv and now we have finished the REZOLV study,” said Nikolaj Sørensen, CEO and president, Orexo. “We have seen a positive uptake in the use of Zubsolv in the U.S. this summer, and with the REZOLV study we strengthen our ability to engage with physicians and payers in optimizing and improving access to treatment of opioid dependence. With the extensive clinical data we can also improve education of new and existing prescribers and thereby enable them to improve their treatment programs for opioid dependence with Zubsolv,” Nikolaj Sørensen continues.