Orexo announced the publication of a manuscript, “A Personalized, Interactive, Cognitive-Behavioral Therapy-Based Digital Therapeutic (MODIA™) for Adjunctive Treatment of Opioid Use Disorder: Development Study,” in the Journal of Medical Internet Research (JMIR) Mental Health. The paper outlines the development and features of a new digital therapeutic, MODIA™. MODIA™ was developed by Orexo in collaboration with GAIA Therapeutics, and, in July, Orexo was pleased to announce the enrollment of the first participant in a clinical evaluation of MODIA™ for the treatment of OUD as part of a clinician-supervised MAT program. Over the next year, MODIA™ will be assessed relative to the current medication assisted treatment approach as well as gauging its ability to provide sustainable positive outcomes for OUD patients.
“For more than a decade, our main focus has been on improving the lives of patients suffering from opioid addiction, an experience which has given us important and unique insights that have been instrumental in the development of MODIA™,” said Mike Sumner, Chief Medical Officer, Orexo. “We know that the ability to combine medication with psychosocial support improves the lives of those struggling with opioid dependence. This paper outlines our innovative new tool that is designed to help advance that treatment and make it more accessible, independent of time or geographical location.”
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OUD patients face a multitude of barriers to receiving treatment, including geographic location, a shortage of qualified health providers, and the heavy weight of stigma, all of which impede access to adequate counseling and the psychosocial support necessary for long-term recovery. MODIA™ is cognitive behavioral therapy (CBT)-based digital therapy that was developed to provide adjunct counseling support. MODIA™ uses an artificial intelligence approach which engages with the patient to enhance the “personal relevance” and “emotional impact” as well as provides tailored content, messaging, and tone to meet the patient’s unique needs and circumstances. The patient only requires basic computer skills and internet access.
MODIA™ was developed in close collaboration with OUD specialists and OUD patients at various stages of recovery. The paper sets forth some of the program content, techniques, and innovative features of MODIA™, including some of the attributes and features specifically developed for the OUD patient as a supplement in the MAT therapeutic approach and to support positive patient outcomes. The paper is authored by Bjorn Meyer, Ph.D. (GAIA Therapeutics), Geri-Lynn Utter, Psy.D. (Orexo US)., and Catherine Hillman, Psy.D.
MODIA™ is a prescription digital therapeutic that has not been evaluated by the FDA (not FDA-cleared). It is marketed under the FDA’s digital health device emergency use guidance (136939). MODIA™ has not been clinically evaluated and may have unknown benefits and risks.
The pivotal, randomized, open-label, parallel-group study will evaluate whether the use of MODIA™ in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce opioid use. The study is designed to enroll an estimated 400 participants aged 18 to 65 across the United States who are voluntarily seeking treatment for documented moderate to severe OUD. Participants will be evaluated over the course of 24 weeks, including a screening period where they will be stabilized on buprenorphine/naloxone, with a primary endpoint defined as the subject having ≥80% of urine drug tests negative for opioids and negative self-reports for illicit opioid use during the study period.