- ReSET-O(TM)* is the first US FDA-cleared prescription digital therapeutic for patients with Opioid Use Disorder
- Cleared by the FDA in December, reSET-O is available immediately
- As part of a broader focus on digital healthcare solutions at Novartis, Sandoz aims to increase patient engagement and improve access to treatment through digital solutions
HOLZKIRCHEN, January 7, 2018 - Sandoz Inc., a Novartis division, and Pear Therapeutics, Inc., announced today the US commercial launch of reSET-O(TM) for patients with Opioid Use Disorder (OUD). reSET-O, cleared by the US Food and Drug Administration (FDA) in December, is immediately available.
The reSET-O prescription digital therapeutic (PDT) is a 12-week cognitive behavioral therapy intended to be used in addition to outpatient treatment. It includes transmucosal buprenorphine, a commonly used medication to treat opioid addiction, and contingency management designed to provide incentives to reinforce positive behaviors. reSET-O is available by prescription only for patients 18 years or older under the care of a clinician.
"The launch of reSET-O provides an important technology-based treatment option for patients with Opioid Use Disorder and may fundamentally change how they interact with their therapies," said Richard Francis, CEO, Sandoz. "At Sandoz, we are proud and excited to push the frontiers of medical innovation."
"Addiction is a chronic and relapsing disease that requires constant support, monitoring and access to treatment," said Corey McCann, M.D., Ph.D, President and CEO of Pear Therapeutics. "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."
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, either with or without the addition of the Therapeutic Education System (TES), which had equivalent content to reSET-O. The clinical trial showed that reSET-O therapeutic content had an overall retention rate of 82.4 percent through the end of 12 weeks of treatment compared with 68.4 percent overall retention rate for patients who did not use reSET-O.
reSET-O also serves as a training, monitoring and reminder tool for healthcare providers by leveraging the Clinician Dashboard. The 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.
When a healthcare provider prescribes reSET-O, the patient is contacted by a patient care specialist and is provided with an access code. The patient then downloads and installs reSET-O on their smartphone or tablet and enters the access code to unlock treatment. After that, the patient can begin working and learning with reSET-O by completing lessons, answering quiz questions, reporting medication usage and reporting substance use, cravings and triggers. All the while, the patient continues to see the clinician in therapy sessions and progress on reSET-O is tracked via the Clinician Dashboard.
Under the terms of a commercial deal announced in April 2018, Sandoz will lead marketing and commercialization of reSET-O and reSET *, Pear’s prescription digital therapeutics for the treatment of Substance Use Disorder and Opioid Use Disorder, respectively. Sandoz launched reSET in November 2018 and now has made reSET-O available to patients in the U.S.
High attrition and relapse rates represent a significant obstacle to providing care to patients with OUD. Therefore, it is important to retain patients in treatment. Retention in treatment is a well-established indicator of successful treatment outcomes for OUD patientsi. The study data demonstrate that reSET-O significantly improved OUD patient retention rates in outpatient treatment.
About Opioid Use Disorder
Every day, approximately 115 Americans die after overdosing on opioidsii. The misuse of and addiction to opioids-including prescription pain relievers, heroin, and synthetic opioids-is a serious national crisis that affects public health as well as social and economic welfare. The Centers for Disease Control and Prevention estimates that the total "economic burden" of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.
reSET-O(TM) Indications for Use
reSET-O(TM) is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only Mobile Medical Application.
Limitation for Use:
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.
This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the full Clinician Brief Summary Instructions for reSET-O for more information.
The reSET-O(TM) prescription mobile medical application is a 12-week (84-day) software application. It is limited to persons with a valid prescription from their licensed provider. reSET-O is intended to be used to increase retention of patients with Opioid Use Disorder in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management to patients currently under clinician care.