First Participant Joins Opioid Use Disorder Treatment Study

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The first participant has officially enrolled in Orexo’s study of digital therapeutic modia, part of a clinician-supervised treatment program for the treatment of opioid use disorder (OUD).¹

“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,” said Nikolaj Sørensen, President and CEO of 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.”¹

In this randomized, open-label, parallel-group study, modia will be evaluated in combination with sublingual buprenorphine/naloxone background therapy to see whether it is superior to sublingual buprenorphine/naloxone alone in reducing opioid use. An estimated 400 participants at 35 sites will be enrolled across the US and evaluated over 24 weeks, including a screening period where they will be stabilized on buprenorphine/naloxone. These participants will be volunteers aged 18 to 65 seeking treatment for moderate to severe OUD.

This news comes just in time to meet a rising need: The opioid epidemic has grown by 36% during the COVID-19 pandemic, with the number of fatal opioid overdoses reaching more than 67,500, from December 1, 2019, to November 30, 2020.²

Additionally, modia aims at helping users develop a customized relapse prevention plan, structured using the responses collected throughout the program.

“A great deal of work went into designing and building modia to deliver a unique digital therapeutic for patients struggling with OUD,” Mike Sumner, Chief Medical Officer of Orexo, said to the press. “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.”¹

References

1. Orexo. Orexo announces first patient enrolled in pivotal study evaluating the efficacy of modia™ in combination with sublingual buprenorphine/ naloxone for the treatment of OUD. News release. July 1, 2021. Accessed July 15, 2021. https://orexo.com/posts/2021-07-01-orexo-announces-first-patient-enrolled-in-pivotal-study-evaluating-the-efficacy-of-modia-in-combination-with-sublingual-buprenorphine-naloxone-for-the-treatment-of-oud

2. Centers for Disease Control and Prevention. Provisional drug overdose death counts. June 16, 2021. Accessed July 15, 2021. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm#dashboard