Orexo starts to test modia™ on patients in collaboration with ApexB.io and Magellan Rx Management

- The Covid-19 pandemic has highlighted the urgent need for additional resources to prevent overdose deaths, which have reached an all-time high with an increase of 21 percent¹

- The medication-assisted treatment (MAT) of opioid use disorder (OUD) requires a combination of drug and therapy treatment, where access and quality of counselling and psychosocial support are one of the main barriers to successful treatment

- modia™ can help those with OUD by providing access to an evidence-based digital therapy rooted in cognitive behavioral techniques

UPPSALA, Sweden, Feb. 10, 2021 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY) today announces the company will collaborate with ApexB.io and Magellan Rx Management to further research on the use of modia™, a digital therapeutic designed for individuals with opioid use disorder (OUD), by establishing a novel, real-world evidence approach. modia™, offers individuals with OUD access to tailored, interactive psychotherapy interventions through their mobile device or computer.

This relationship will provide further data behind the need for an easily accessible digital treatment option for OUD. This is a critical time for such a treatment option as the Centers for Disease Control and Prevention (CDC) recently called for expanded efforts related to the prevention of overdose deaths during the pandemic. The US has experienced more than 83,000 deaths as a result of overdoses, an increase of 21 percent which is the highest increase recorded ever in a 12-month period.²

Nikolaj Sørensen, President and CEO, said: "Our decision to enter digital therapies came from feedback from physicians and payers about lack of access to psychological support to patient being prescribed ZUBSOLV® or similar products. The agreement with a group of leading payers to collect real world evidence from patients using modia™ in combination with a buprenorphine product is a testimony to the genuine interest that exist to make new treatment tools available. Proving the clinical value of modia™ is critical to ensure patients get the help and recovery they need, and to unleash the full commercial potential of modia™."

"The Covid-19 pandemic has had a profound impact on opioid use in the US, accelerating the number of overdose deaths in the last year alone," said Dennis Urbaniak, Executive Vice President Digital Therapeutics, Orexo US. "It's our duty to do everything in our power to bring modia™ to market quickly and ahead of the initial schedule so we can aid in the effort to save lives. We're grateful to have partners like ApexB.io and Magellan Rx Management who are ready to help us do just that."

A combination of drug and therapy treatment, or medication-assisted treatment (MAT), is recommended for individuals with OUD, however, only 36 percent of healthcare providers report an adequate number of counselors in their area.3 With this in mind, modia™ was designed to help close the gap in care by providing access to quality, evidence-based therapeutic interventions rooted in cognitive behavioral therapy and other effective psychotherapeutic techniques.

Last year, Orexo also accelerated the launch of two additional digital therapeutics, deprexis® and vorvida®, which help address depression and problematic or harmful alcohol use respectively, in response to increased mental illness during the Covid-19 pandemic.

The first payers have agreed to provide participants to the trial and additional payers are expected to join in the future. A broader launch of modia™ in the US is expected in H2 2021.

For further information, please contact:

Orexo AB (publ.)

Nikolaj Sørensen, President and CEO
Tel: +46 (0)18 780 88 00
E-mail: ir@orexo.com

Dennis Urbaniak, EVP Digital Therapeutics 
Tel: +1 (0)855 982 7658 
E-mail: ir@orexo.com  

Lena Wange, IR & Communications Director
Tel: +46 (0)18 780 88 00
E-mail: ir@orexo.com

About Orexo

Orexo develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. The products are commercialized by Orexo in the US or via partners worldwide. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercializes its lead product ZUBSOLV® for treatment of opioid use disorder. Total net sales for 2020 amounted to SEK 664 m and the number of employees was 138. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The company is headquartered in Uppsala, Sweden, where research and development activities are performed.

For more information about Orexo please visit, www.orexo.com. You can also follow Orexo on Twitter, @orexoabpubl, LinkedIn and YouTube.

About ApexB.io

Apex health is a boutique consulting company providing strategic guidance and analytics to life-sciences and healthcare companies to help understand patient journey, conduct real world research and achieve optimal market access. ApexB.io team has expertise in design and launch of digital therapeutic solution that improve clinical outcomes and enhance patient engagement. ApexB.io leverages it's propriety curio digital therapeutic platform for "end to end "technology solution for Digital Therapeutics that provides workflow integration and data capture. ApexB.io has multiple industry as well as academic partnerships to conduct real world studies that provide insights into patient journey and unmet need.

About Magellan Rx Management

Magellan Rx Management, a division of Magellan Health, Inc., is shaping the future of pharmacy. As a next-generation pharmacy organization, we deliver meaningful solutions to the people we serve. As pioneers in specialty drug management, industry leaders in Medicaid pharmacy programs and disruptors in pharmacy benefit management, we partner with our customers and members to deliver a best-in-class healthcare experience. 

The information was submitted for publication at 8.00 am CET, on February 10, 2021.

^[1] June 2019 - June 2020 vs. June 2018 - June 2019 (https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm#dashboard)

^[2] June 2019 - June 2020 (https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm#dashboard)

^[3] Researchers specifically surveyed physicians actively prescribing buprenorphine (N = 1174)

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