Orexo Completes 1,080 Patient REZOLV Study and Reports on Improved Treatment of Opioid Dependent Patients

Regulatory News:

Orexo AB (publ.) (STO:ORX) announces 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 US aimed at optimizing the treatment of opioid dependence.

The opioid epidemic in the US continues to increase, and with recent legislative changes in the US that expand access to treatment, the current annual growth of nearly 9 percent of patients treated is expected to accelerate significantly. During the past 3 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 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.

"The finalization of the REZOLV study is one more important milestone we have reached during the summer. In June we signed an ex-US 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,” says Nikolaj Sørensen, CEO and President, Orexo AB. "We have seen a positive uptake in the use of Zubsolv in the US 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.

About Orexo

Orexo is a specialty pharmaceutical company commercializing its proprietary product Zubsolv for treatment of opioid dependence in the US. Zubsolv is an advanced formulation of buprenorphine and naloxone using Orexo’s unique knowledge and expertise in sublingual drug delivery. R&D is focusing on reformulation of known substances to new improved products that meet great unmet medical needs by using its patented proprietary technologies. Orexo’s share is listed on Nasdaq

Stockholm Exchange Mid Cap (STO:ORX) and is available as ADRs on OTCQX (ORXOY) in the US. Orexo’s global headquarters and R&D are based in Uppsala, Sweden.

For information about Orexo please visit www.orexo.com or follow us on Twitter, @orexoabpubl.

About REZOLV

The REZOLV study was a medical record review conducted to examine and characterize the impact of treatment and psychosocial factors on the early outcomes of patients who utilized Zubsolv® therapy for opioid dependence. The data was collected from 1,080 patients being treated by 134 physicians across 87 US treatment sites of which 80 were private practices and 7 were institutional sites. The data collected included a profile of the medical practice and the treating physicians at each site, in addition to the scope of addiction treatment services and treatment standards employed. Individual patient data included demographics, medical, psychosocial and drug abuse histories, along with details of the individual addiction treatment program and progress over the first 28 days of therapy with Zubsolv or up to the point of discontinuation.

Of the 1,080 total patients from which information was gathered, 978 were confirmed to be evaluable for treatment. Evaluable patients were defined as those who had completed 28 days of Zubsolv treatment and had a follow-up drug screen, or completed less than 28 days of treatment due to non-compliance, had requested a change in medication, or required a higher level of care. From the patients evaluable for treatment, 77.6 percent (n=759) were determined to have been a treatment success, defined by an evaluable patient who completed 28 days of treatment and tested negative for opiates on the last follow-up drug screen.

The information was submitted for publication at 08:00 am CET, September 2, 2016.

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