The opioid epidemic has reached critical proportions in the United States, with more than 115 people dying from opioid overdose every day. In response to a crisis created by pharmaceuticals, some companies are looking to digital tools as part of the solution to opioid use disorder.

Novartis subsidiary Sandoz and Pear Therapeutics have received FDA clearance for their reSET-O app-based therapy meant to increase retention for opioid addicts in outpatient treatment programs.

The prescription mobile application is directed at supporting patients in treatment using buprenorphine as a medicinal aid to overcome opioid addiction. Over the course of 12 weeks, users of the application take part in programs and exercises geared at eliminating positive reinforcement for opioid use and enhancing positive reinforcement for sobriety.

reSET-O also facilitates communication between the clinician and patient through the ability to report cravings, triggers and adherence to their buprenorphine therapy.

In a signal about the need to tackle the opioid crisis, the FDA has made therapeutic solutions to opioid use disorder a priority. reSET-O was granted an Expedited Access Pathway designation by the government last year, which includes fast-track review of its regulatory submission.

The FDA also recently announced the winners of its Opioid Innovation Challenge, which was meant to identify and hasten the development of promising therapies and products to treat opioid addiction. The chosen companies get a chance to collaborate with the FDA on the regulatory pathway for their products and receive expedited review when they make a formal application.

“There is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy,” Pear Therapeutics CEO and President Corey McCann said in a statement.

The FDA’s clearance decision was based in part on a randomized clinical trial sponsored by the National Institute on Drug Abuse which found that use of the reSET-O application “significantly improved” retention in outpatient treatment when compared to a control group.

Medication assisted treatment for opioid addiction is still relatively rare, with only around 13 percent of outpatient clinics in the U.S. offering the therapy. The companies are hoping that the release of reSET-O will create a clinical standard to boost the adoption of medication assisted treatment, helping both Novartis and Pear Therapeutics in the process.

Pear Therapeutics previously developed the prescription reSET application, which is aimed at individuals taking part in outpatient therapy for some forms of drug and alcohol addiction.

Novartis and Pear Therapeutics struck a partnership earlier this year with the goal of developing digital therapies to support the products developed at the pharmaceutical company. Under the terms of the deal, Novartis is leading commercialization and marketing efforts for both reSET and reSET-O.

Besides their work together in substance abuse conditions, the two companies are also collaborating on a digital therapeutic called THRIVE, meant to help patients diagnosed with schizophrenia.

“One of the challenges with treating people with diseases of the brain is that there are few good therapeutic options,” Pear Therapeutics Chief Medical Officer Yuri Maricich told MedCity News in March. “What this partnership identifies is a prescription therapeutic that will bring a whole new modality for treatment to a patient population that has not had adequate treatment options. This offers another way to enhance them.”

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