In a ground-breaking move, digital healthcare firm Pear Therapeutics seeks FDA approval for its addiction management software.
The software allows the patient to experience cognitive behavioural therapy techniques via a device rather than face to face with a professional. A number of clinical trials have shown that this method is more effective than conventional therapies, and now the company behind the initiative, Pear Therapeutics, is looking to the FDA to approve their product to be prescribed by doctors.
Statistics have unfortunately shown that the opioid epidemic is growing ever more rapidly, and new forms of treatment are being called for. Digital healthcare is set to grow to become a $6 billion market in the near future, according to analysts at Goldman Sachs. Digital therapeutics developers have been working with fast-track companies to help with FDA 510k approval in order to get their products to the market as quickly as possible. Pear Therapeutics are expecting to receive approval for their application this year.
The software, known as reSET, aims to improve rates of abstinence and increase retention rates for people undergoing rehab programmes. The content is based on cognitive behavioural therapy, but some of the modules also aim to address the root causes and social effects of addiction. See http://www.medscape.com/viewarticle/874490 for details of reSET’s success in clinical trials.
It is thought that environmental factors contribute significantly to success rates for reducing dependence on drugs and alcohol. For this reason, digital solutions could make a difference for many patients. Our devices and smartphones are so integral to our lives now that we can utilise them to help us change our behaviours.
Industry experts like http://www.fdathirdpartyreview.com/ can help facilitate the journey to FDA approval for digital healthcare providers. Pear Therapeutics have described this as a “watershed moment” for digital healthcare.
The reSET app changes behaviours by instilling new ways of thinking about drugs and alcohol. Approaches to resisting and refusing substances are taught, and abstinent behaviour is reinforced. Clinical trials have demonstrated that the app has greater retention rates than conventional therapy, and it is also more effective at achieving abstinent behaviours, performing better than the regular treatments for a number of different abstinence measurements.
Pear Therapeutics have warned that their software is not a panacea, however, and must be prescribed for use under the supervision of a psychiatrist.