FDA https://www.fda.gov has cleared a mobile medical app to help increase the amount of time a patient participates in an outpatient treatment program for Opioid Use Disorder (OUD).
The app referred to as “reSET-O” is the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder (OUD). Pear Therapeutics is leading the development of the new therapeutic class with two FDA authorized PDTs, and a robust pipeline of therapeutics across disease areas.
According to FDA Commissioner Scott Gottlieb, M.D, “Medical devices including digital health devices like mobile medical apps have the potential to play a unique and important role in contributing to these treatment efforts.”
The reSET-O app can be downloaded directly to a patient’s mobile device after receiving a prescription from their doctor. It is intended to be used while participating in an outpatient OUD treatment program.
It can be used as a training, monitoring, and reminder tool for healthcare providers and patients in maintaining an outpatient treatment program and includes a compliance reward system such as earning special icons on a prize wheel within the app.
The app supports clinician-patient communication between visits by providing a means for patients to self-report cravings, triggers, and buprenorphine use plus reSET-O also reinforces the importance of using buprenorphine for treating OUDs.
The app works using the Community Reinforcement Approach (CRA) and engineered to deliver Cognitive Behavioral Therapy (CBT) for patients with OUD. reSET-O delivers CRA therapy as a series of interactive therapy lessons. Each therapy lesson is comprised of a CBT component and skill building exercise. Therapy lessons are delivered primarily via text or audio, and may include videos, animations, and graphics.
To support the reSET-O submission to FDA, the National Institute on Drug Abuse sponsored a clinical trial to evaluated 170 patients with OUD over a period of twelve weeks. Patients were randomized to receive either Treatment-as-Usual (TAU) which consisted of standard clinician interactions in conjunction with buprenorphine or to use the reSET-O app along with standard clinician interactions in conjunction with buprenorphine.
At the end of the study, patients were randomized to reSET-O CBT when used with outpatient treatment and contingency management. It was found that these patients significantly improved among patients with buprenorphine plus contingency management treatment experience.
Sandoz Inc. https://www.sandoz.com, a division of Novartis has been working with Pear Therapeutics Inc. https://pearltherapeutics.com on the app and will lead the marketing and commercialization of reSET-O and reSET. Sandoz plans to launch reSET-O in the coming days in the U.S.