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FDA clears Sandoz and Pear’s Opioid Use Disorder app

The app incorporates CBT to improve high relapse rates


The FDA has approved the use of a mobile phone app to help those with Opioid Use Disorder (OUD), a follow up to Pear Therapeutic's first ever 'digital therapeutic' approved by the US regulator last year.

Known as reSET-O, the new app was developed by Pear Therapeutics in collaboration with Sandoz, (the generic and biosimilars arm of Novartis) and represents an expansion in Pear's clinically-validated software-based therapeutics, known as Prescription Digital Therapeutics (PDT).

Sandoz's interest in the field is based on it being one of several firms marketing buprenorphine products, the opioid treatment used to wean patients off their dependency on other opioid therapies, be that prescription medications or street drugs.

Its partnership with Pear Therapeutics reflects the growing need for pharma companies to go 'beyond the pill' and offer health systems and patients support in staying on their medication.

The app offers users a 12-week programme, leveraging the use of cognitive behavioural therapy (CBT) to increase retention of patients with OUD in outpatient treatment.

The app is approved as part of a medication-assisted-treatment approach, which combines the use of CBT and medications to treat substance use disorders for patients 18 years or older and who are currently under the supervision of a healthcare professional.

"Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way," said Richard Francis, CEO, Sandoz.

Corey McCann

Richard Francis, CEO, Sandoz

"New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes. At Sandoz, we are proud to be a joint pioneer in this exciting new field."

The app is backed with some promising clinical trial evidence, which saw 170 patients with OUD complete the suggested 12-week programme.

The study found that those using reSET-O CBT combined with outpatient treatment and contingency management experienced significantly improved retention.

High levels of patients relapsing into opioid dependency is a major part of the problem, particularly in the US, which has reached crisis levels in the country in recent years.

Corey McCann, President and CEO of Pear Therapeutics, said: “Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the US in 2017. There is an urgent need for new and innovative therapeutics to address this public health epidemic.”

Pear Therapeutics’ solution is modelled on the Community Reinforcement Approach (CRA), an alcoholism management programme that identifies and subsequently eliminates triggers that contributes to substance abuse.

That particular app was designed for the treatment of patients with Substance Use Disorder (SUD), and claimed to improve clinical outcomes in a disease.

McCann added: “This ground breaking 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."

Since the US government declared OUD as an epidemic last year it has been encouraging an uptake in finding solutions for the crisis.

The Centers for Disease Control and Prevention estimates that the total economic burden of prescription opioid misuse in the US alone equates to $78.5bn a year, taking into account the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

Article by
Gemma Jones

11th December 2018

From: Regulatory



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