Since 2013 Orexo is established in the US with an own sales force. Today US Pharma consists of the lead product ZUBSOLV®, for the treatment of opioid use disorder. On a daily basis our sales representatives visits physicians, medical clinics and minor hospitals with the aim to improve life for people who are dependent on opioids.

3 Questions with Robert A. DeLuca, President of Orexo US Inc.

Despite the impact of the pandemic on market growth and reduction of face to face interactions with our customer base especially MDs/ HCPs, I am quite pleased with the stability and resilience of ZUBSOLV® and the US team. The US Pharma business delivered in its 8th full year a strong profit and sustainable cash enabling continued investments in the pipeline and in digital therapeutics.

To continue to deliver solid pharma profits and cash flows while building on the launch and sales of the digital portfolio, which has strong synergies with our sales force, and also preparing for the launch of OX124 in 2023. In addition, with MODIA® available we will increase our efforts to improve the availability of MAT for OUD patients. I also continue to seek business development opportunities to further strengthen our product portfolio.

The US organization is consistently outperforming its prior years internal revenue targets by driving sales to a much higher level where the company becomes less dependent on ZUBSOLV® revenue through sales from pharma generated from the pipeline, the digital therapies and newly acquired products. Additionally, we have a pipeline of development projects to fuel the organization in the following 5 years.

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 and in the EU ZUBSOLV® is commercialized by Orexo´s partner Accord Healthcare. Rights to other markets are owned by Orexo.
Partner
Patent protection   In all major markets until 2032

 

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

11,020,387

11,020,388

11,433,066