Orexo Enrolls the First Patient in a Pivotal Study Evaluating the...

Orexo Enrolls the First Patient in a Pivotal Study Evaluating the Efficacy of modia in Combination with Sublingual Buprenorphine/Naloxone in the Treatment of Opioid Use Disorder

Healthcare Tech Outlook | Thursday, July 15, 2021

Nikolaj Sorensen, Chief Executive Officer, Orexo

Orexo brings eight years of experience serving the U.S. OUD market to the research effort.

FREMONT, CA: Orexo, a Swedish pharmaceutical company focused on the advancement of pharmaceuticals and digital therapies in the growing field of mental illness and addiction disorders, enrolls the first participant in the pivotal study of digital therapeutic modia™ in combination with sublingual buprenorphine/naloxone, as part of a clinician-supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD).

The randomly selected, open-label, parallel-group study determines whether modia™ combined with sublingual buprenorphine/naloxone background therapy is more effective at reducing illicit opioid use than sublingual buprenorphine/naloxone alone. The study's objective is to enroll approximately 400 participants at 35 locations throughout the United States seeking treatment for documented moderate to severe OUD.

Orexo brings extensive category expertise to the research effort, having served the US OUD market extensively over the last eight years, most notably with ZUBSOLV® (buprenorphine and naloxone) sublingual tablets.

“When it comes to treating OUD, research has proven time and time again that we need to take a whole-person approach by addressing both the physical withdrawal symptoms and the mental health issues associated with addiction,” says Nikolaj Sørensen, President and CEO, Orexo. “Yet, all too often, the resources needed to effectively do so just aren’t available. The enrollment of our first patient in the pivotal study of modia™ is a significant milestone toward closing that treatment gap and allowing more people easy access to a tool designed to support them in the battle against addiction.”

The opioid epidemic has continued to grow throughout the COVID-19 pandemic, with over 67,500 fatal opioid overdoses occurring between December 1, 2019, and November 30, 2020, a 36 percent increase. Expanding access to new, innovative treatments like modia™ may aid in reversing the epidemic's progression.

“A great deal of work went into designing and building modia™ to deliver a unique digital therapeutic for patients struggling with OUD,” says Mike Sumner, Chief Medical Officer, Orexo. “We fully anticipate that the outcomes of the study will prove that modia™ can be a valuable addition to existing treatment plans for patients with OUD when paired with medications like buprenorphine/naloxone.”

modia™ has been developed in collaboration with GAIA, a leading global DTx company headquartered in Hamburg, Germany. GAIA has over two decades of experience developing industry-leading DTx evidence across multiple therapeutic categories. In addition to GAIA's extensive research experience and Orexo's expertise in OUD, modia™ was developed and initially tested by patients with OUD, providing a highly unique patient perspective that drives the therapeutic experience.

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