Preventing Opioid Use Disorder with reSET-OTM
Sandoz is an international leader in generic and biosimilar medicines. The firm, an integral part of the Novartis Group, discovers new ways to enable people to extend their lives. With ground-breaking, new approaches to help people around the world access high-quality medicine, Sandoz contributes to effectively addressing healthcare needs. In 2017, the company’s sales amounted to around $10.1 billion, covering the portfolio of roughly 1,000 molecules in all major therapeutic areas, and their products reached more than 500 million patients in 2017.
When it comes to digital prescription therapies, Pear Therapeutics is a leading company. In order to improve patient outcomes and better engagement, and tracking tools for clinicians, the company redefines medicine by providing clinically validated software-based therapeutics. Pear has a product pipeline across therapeutic areas including severe mental and neurological conditions. Pear has a product pipeline. The lead product of Pear, reSET, treated the drug use disorders and received FDA marketing authorization in the field of disease for the first digital prescribed therapy. The FDA approved marketing clearance in December 2018 for Pear's second product, reSET-O(TM), for treatment of the Opioid Use Disorder.
The U.S. commercial release of reSET-O(TM) for patients with Opioid Use Disruption (OUD) has recently been announced by Sandoz Inc, Novartis division and Pear Therapeutic, Inc. ReSET-O is available immediately, cleared in December by the Food and Drug Administration of the U.S. (FDA).
The reSET-O Digital Therapeutic Prescription (PDT) is an outpatient 12 weeks of cognitive behavioral therapy. It includes Transmucosal buprenorphine, a common drug used to treat opioid addiction and contingency management to encourage positive behavior. Only patients 18 years old or older under clinic care are available with a prescription for reSET-O.
The efficacy of the reSET-O was measured with or without the addition of the reSET-O equivalent therapeutic education system (TES), in a crucial randomized test of 170 patients seeking OUD therapy, supervision of the treatment with supervised buprenorphine paired with a program of conduct therapy. The clinical trial showed that the total retention rate of reSET-O therapy for patients not taking reSET-O was 82.4 percent for 12 weeks of the treatment, compared to 68.4 percent in total.
reSET-O also provides healthcare providers with the clinician dashboard as a training, monitoring, and reminder tool. The dashboard allows clinicians to gain a broader view of the recovery progress of their patients, including reported adhesion to patients’ buprenorphine so that more transparency can be achieved during in-person therapy.