Treatment App Available by Prescription for Adults With Opioid Use Disorder

An FDA-approved mobile application for adults with opioid use disorder (OUD) is now available by prescription.¹ Pear Therapeutics’ reSET-O app aims to increase patient retention for outpatient treatment programs.^1-3

The new app, a cognitive behavioral therapy (CBT) that can be downloaded to a patient’s mobile device,^2,3 is intended to be used in addition to outpatient treatment under the care of a health care professional. The app should also be used in conjunction with treatment that includes a behavior modification intervention that establishes a connection between new, targeted behavior; buprenorphine and contingency management; and the opportunity to obtain a desired reward, according to the FDA.²

“Addiction is a chronic and relapsing disease that requires constant support, monitoring and access to treatment,” said Corey McCann, M.D., PhD, President and CEO of Pear Therapeutics, in a prepared statement.¹ “We believe prescription digital therapeutics can transform the way clinicians treat addiction by providing a way for patients to access treatment when and where it’s needed. reSET-O has been clinically proven to increase the likelihood that a patient will remain in treatment, while also providing a way for patients to access treatment anytime, anywhere, under clinician supervision.”

Approved by the FDA in December 2018, reSET-O is a 12-week interval prescription digital therapeutic that is modeled on the Community Reinforcement Approach (CRA) and engineered to deliver CBT for patients with OUD. The app provides CRA therapy as a series of interactive therapy lessons, of which each is comprised of a CBT component and skill-building exercises. Therapy lessons are delivered primarily via audio or text and may include animations, graphics, and video.³

When a healthcare provider prescribes reSET-O, the patient is contacted by a patient care specialist and is provided with an access code. After installing the app, the patient can complete lessons, answer quiz questions, report medication usage and report substance use, cravings and triggers. Meanwhile, the patient continues to see the clinician in therapy sessions and progress on reSET-O is tracked via the Clinician Dashboard.¹

“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," FDA Commissioner Scott Gottlieb, MD, said in a statement.² "Providing Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed."

More than 80% of patients with OUD do not receive or seek out care, and just 13% of outpatient facilities in the United States offer medication-assisted treatment (MAT), according to Pear Therapeutics. “Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,” said McCann, in a prepared statement.³

According to Pear Therapeutics, reSET-O could have the potential to dramatically affect this gap in treatment by delivering multi-modal therapy in combination with MAT in a way that is designed to be convenient, easy to access, and more effective for clinicians and patients. This app helps to provide enhanced and standardized care for OUD, offering particular benefit in areas where access to care is inconsistent or unavailable.³ reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD, according to the FDA.²

The efficacy of reSET-O was evaluated in a pivotal, randomized trial of 170 patients seeking treatment for OUD, who received supervised buprenorphine treatment paired with a behavior therapy program. These patients were being treated either with or without the addition of the Therapeutic Education System (TES), which had equivalent content to reSET-O.¹

The clinical trial showed that reSET-O therapeutic content had an overall retention rate of 82.4% through the end of 12 weeks of treatment compared with 68.4% overall retention rate for patients who did not use this app. The mobile tool also serves as a training, monitoring and reminder tool for health care providers by leveraging its Clinician Dashboard. This dashboard helps clinicians gain deeper insights into their patients’ progress toward recovery, including patient-reported buprenorphine adherence to allow for more transparency during in-person therapy sessions.¹

Data from the clinical studies did not indicate any adverse effects associated with use of the program used in the trial. The adverse events evaluated were typical of patients with OUD, including cardiovascular disease; depression; gastrointestinal diseases; hepatitis C; HIV; mania; nutritional diseases; risk of overdose; and suicidal attempts, behavior, and ideation.³

A version of this article was originally published at ContemporaryClinic.com.

References

• Sandoz and Pear Therapeutics Announce US Launch of reSET-O™ to Help Treat Opioid Use Disorder [news release]. Boston, MA; January 7, 2019: Pear Therapeutics. https://www.businesswire.com/news/home/20190107006050/en?rel=0" . Accessed January 8, 2019.
• FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs [news release]. Silver Spring, MD; December 10, 2018. FDA website. .fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628091.htm. Accessed December 10, 2018.
• Sandoz INC. and Pear Therapeutics obtain FDA clearance for reSET-O to treat opioid use disorder [news release]. Boston, MA; December 10, 2018; Pear Therapeutics website. peartherapeutics.com/sandoz-inc-and-pear-therapeutics-obtain-fda-clearance-for-reset-o-to-treat-opioid-use-disorder/. Accessed December 10, 2018.