Digital Therapeutic MODIA™ Designed to Improve Medication-Assisted Treatment Experience for Opioid Use Disorder

Rhea-AI Summary

Orexo announced the publication of a manuscript detailing the MODIA™ digital therapeutic for Opioid Use Disorder (OUD). Developed with GAIA Therapeutics, MODIA™ combines cognitive behavioral therapy with artificial intelligence to enhance treatment accessibility. Currently in a clinical evaluation phase, the study aims to assess MODIA™'s effectiveness alongside traditional medication-assisted treatment (MAT). The pivotal study will involve 400 participants across the U.S., focusing on reducing opioid use over 24 weeks. MODIA™ has not yet received FDA evaluation and may present unknown risks.

Positive

• MODIA™ is developed to enhance the treatment of Opioid Use Disorder, addressing a significant healthcare need.
• The use of AI in MODIA™ aims to provide personalized therapy for patients, making treatment more relevant and impactful.
• A pivotal study enrolling 400 participants indicates robust clinical evaluation and potential for positive patient outcomes.

Negative

• MODIA™ has not been evaluated by the FDA and may have unknown benefits and risks.

MORRISTOWN, N.J., Oct. 18, 2021 /PRNewswire/ -- Today 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.

MODIA™ was developed in close collaboration with OUD specialists and OUD patients at various stages of recovery.

"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."

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.

About the Pivotal MODIA^™ Study

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.  For more information about the study, please visit www.clinicaltrials.gov.   

About Orexo DTx

Orexo DTx is the digital health arm of Orexo AB, a pharmaceutical company that develops and commercializes improved pharmaceuticals and digital therapies. The company addresses unmet needs within the growing space of mental illness and substance use disorders. Orexo DTx was created in Q4 of 2019 and in the second half-year of 2020 vorvida^®, for alcohol misuse, and deprexis^®, for depression, were launched in the US while, MODIA^™, for opioid use disorder, is expected to be launched in in the second half-year 2021. All digital therapies are in partnership with the GAIA group.

Orexo DTx's mission is to redefine treatment of addiction by offering clinically validated digital therapeutics to ensure more successful treatment for patients and cost-effective solutions for payers.

The digital products are commercialized by Orexo DTx initially in the US where Orexo also commercializes its lead product ZUBSOLV^® (buprenorphine and naloxone) sublingual tablets (CIII) for treatment of opioid use disorder.

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

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SOURCE Orexo U.S.

FAQ

What is MODIA™ and how does it help with Opioid Use Disorder?

MODIA™ is a digital therapeutic based on cognitive behavioral therapy, designed to support patients with Opioid Use Disorder by enhancing accessibility and relevance through an AI-driven approach.

When did Orexo announce the clinical evaluation of MODIA™?

Orexo announced the enrollment of the first participant in the clinical evaluation of MODIA™ in July.

What is the primary focus of the pivotal study for MODIA™?

The pivotal study aims to evaluate whether the use of MODIA™ in combination with medication is superior to medication alone in reducing opioid use.

How many participants will be involved in the MODIA™ clinical study?

The clinical study aims to enroll approximately 400 participants aged 18 to 65 across the United States.

Is MODIA™ FDA-approved?

No, MODIA™ has not been evaluated by the FDA and is marketed under emergency use guidance.