In April 2018, Pear Therapeutics and Sandoz formed a commercialisation partnership for Pear’s leading pipeline assets, reSET and re-SET-O. The deal would combine Pear’s expertise in software-based therapeutics with Sandoz’s global reach and strong marketing force.

Last month, reSET reached the market as the first and only FDA-approved digital therapeutic for patients with substance use disorders involving alcohol, cocaine, marijuana, and stimulants. On 10 December 2018, re-SET-O received the green light from the FDA specifically to help increase retention in an outpatient treatment programme for people with opioid use disorder (OUD), with a US launch planned before the end of the year. Under the terms of the deal, Sandoz will lead marketing and commercialisation of both reSET and re-SET-O in the US.

re-SET-O is indicated as a prescription-only medical app that provides cognitive behavioural therapy (CBT) as an adjunct to outpatient treatment that includes buprenorphine (medication-assisted treatment, or MAT) and contingency management. MAT is seen as one of the most effective ways to overcome opioid addiction, combining FDA-approved medication with behavioural services.

However, high attrition and relapse rates represent a notable problem for this patient population. Re-SET-O is designed specifically to address this challenge by keeping patients more engaged with their treatment programme by including a compliance reward system within the app. In addition, it can serve as a training, monitoring, and reminder tool for both the patient and the healthcare provider, and facilitate communication between visits, allowing patients to self-report cravings.

The number of deaths caused by opioid overdoses has been steadily increasing over the last decade, most noticeably in the US, which has become the world’s top prescriber of opioid painkillers and therefore resulting in the opioid epidemic. Despite the epidemic levels of both medical and non-medical opioids such as heroin and fentanyl, only a minority of these patients who need MAT can actually access it.

According to GlobalData’s recent Opioid Use Disorder (OUD) report, access barriers were noted as one of the main unmet needs in this market, due to the high annual cost of therapy combined with the fact that many of those who are abusing opioids find it difficult to hold down a steady job or lack medical insurance. Therefore, despite the significant patient pool in the US, only a minority of patients are diagnosed with OUD.

Re-SET-O certainly has the potential to target this gap in the market, and by utilising it in conjunction with pharmacotherapy, it is expected to improve health outcomes of patients and help to address this public health epidemic. From a commercial standpoint, Pear and Sandoz will reap the rewards from this innovative product, given that buprenorphine-based brands generated 65% of the OUD market in the US, currently valued at $1.7bn.