UPPSALA, Sweden, Oct. 28, 2022. Orexo AB (publ.), today announces the last participant has enrolled in the pivotal study of the digital therapeutic MODIA as part of a clinician supervised medication-assisted treatment program for the treatment of opioid u-News Center-Changzhou Extraordinary Pharmatech co.,LTD-

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UPPSALA, Sweden, Oct. 28, 2022. Orexo AB (publ.), today announces the last participant has enrolled in the pivotal study of the digital therapeutic MODIA as part of a clinician supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD). The randomized, open-label, parallel-group study is evaluating whether the use of MODIA in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce illicit opioid use. The study enrolled 437 participants at 35 sites across the US who voluntarily sought treatment for documented moderate to severe OUD.

Orexo brings deep category expertise to the research effort, having served the US OUD market extensively over the last nine years through its efforts with ZUBSOLV (buprenorphine and naloxone) sublingual tablets.

"The medically assisted treatment of OUD requires a complete treatment plan that includes psychosocial support," said Nikolaj Sørensen, President and CEO of Orexo. "However, access to quality counselling remains one of the main barriers to successful treatment in many areas of the US. Our aim is to increase access to behavioural treatment to aid in the whole-person approach to overcoming OUD."

The US opioid epidemic has claimed one million lives over the past two decades and is being driven by illicit opioids.The opioid epidemic has worsened during the COVID-19 pandemic. More Americans died of drug overdoses in 2021 than any previous year, including more than 80,000 deaths involving opioids.

MODIA has been co-developed with GAIA, a leading global DTx company based in Hamburg, Germany, which has over two decades of industry leading DTx evidence development across multiple therapeutic categories. In addition to GAIA's significant research experience and Orexo's expertise in OUD, patients with OUD were also included in the development and initial product testing of MODIA, offering a highly unique patient perspective that drives the therapeutic experience.

About MODIA

MODIA is intended to provide digital cognitive behavioral therapy for patients with opioid use disorder (OUD), 18 years of age or older, as part of a clinician supervised medication-assisted treatment program for opioid use disorder (OUD). In addition, MODIA helps users develop a customized relapse prevention plan based on the responses collected from the exercises throughout the program. Orexo who owns the global rights to MODIA is aiming to get a prescription digital therapeutics clearance from the FDA, based on the results from the pivotal MODIA study expected mid-2023 using the 510 K pathway.

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