Pharmaceuticals

Zubsolv®

Zubsolv is indicated for the maintenance treatment of opioid use disorder (OUD) and should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. The drug is based on Orexo´s sublingual drug delivery platform and is available in six dosage strengths.

Orexo commercializes Zubsolv in the US. In the EU, Zubsolv is commercialized by Orexo´s partner Accord Healthcare. Rights to other markets are owned by Orexo.

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Retrospective Evalutation of Zubsolv Outcomes - A Longitudinal View

The REZOLV study - completed in 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.

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

Medical guide

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Abstral^®

Abstral is indicated for treatment of breakthrough cancer pain, developed based on the company´s sublingual drug delivery platform.

Grunenthal Med. provides commercialization of Abstral outside the US and EU, where patents have expired.

Edluar^®

Edluar is indicated for the treatment of short-term insomnia, developed based on the company´s sublingual drug delivery platform.

Viatris provides commercialization of Edluar worldwide outside the US.

Digital mental health programs

Therapies developed in consultation with psychologists, physicians and patients. All are based on cognitive behavioural therapy techniques that empower patients in their efforts to make behaviour and lifestyle changes. These therapies can be used privately and are available 24 hours a day, helping to reduce the stigma that is often associated with OUD and mental illness.

MODIA®

MODIA for OUD

MODIA is a 6-month digital mental health program designed to help patients with OUD develop behavioral coping skills. MODIA incorporates various supportive techniques like cognitive behavioral therapy (CBT) and motivational interviewing. MODIA is intended for use by patients who are engaged in a clinician-directed Medication Assisted Treatment (MAT) plan for OUD.

Developed in collaboration with GAIA AG. Orexo owns the global rights.

Learn more about MODIA

Vorvida®

Vorvida for alcohol manangement

Vorvida is a 6-month digital mental health program to help individuals reduce their alcohol use and help them manage their drinking behavior. Vorvida uses CBT-based tools and techniques to help patients identify triggers, break negative behaviors, and develop healthier responses to alcohol. The effectiveness of vorvida is evaluated in randomized clinical trial, including approximately 600 patients.^{1, 2, 3}

In-licensed from GAIA AG for the US market.

Learn more about Vorvida

References: 1. vorvida Instructions for Use. Jan 2023. 2. Zill J, et al. Dtsch Arztebl Int. 2019;116(8):127-133. 3. Carroll KM, Psychol Addict Behav. 2017;31(8)847-861.

Deprexis®

Deprexis for depression

Deprexis is a 3-month digital mental health program that can help people create more positive thoughts and behaviors using trusted CBT-based techniques. Its effectiveness has been evaluated and published in 12 randomized clinical trials (RCTs) including more than 2,800 patients. Deprexis can be added to any treatment plan.^{4, 5, 6, 7}