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Boston-based Pear Therapeutics filed a submission to the US Food and Drug Administration (FDA) seeking marketing authorization for Somryst, a prescription digital therapeutic intended for use in the treatment of adults with chronic insomnia and depression. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers.

Digital tech is also being used to help support patients on traditional medications — notably patients living with diabetes.

“FDA approves first therapeutic videogame“, Endpoints News, June 2020, @JasonmMast “…Games just became medicine“, The Verge, June 2020, Sean Hollister @StarFire2258 “Prescription videogames may be the future of medicine“, The Verge, July 2017, @LaurenGoode “Can ‘digital therapeutics’ be as good as drugs? Now the The alliance specifies that a digital therapeutic must be evidence based, clinically validated and used “independently or in concert with medications, devices or other therapies to optimize patient care and health outcomes.” Diabetes management and resources continues to be a major area of interest for big pharma. In Another key area that the pharma industry has been focusing on is using digital tools for research and development. reSET combines patient-facing mobile assessments and interventions with clinician-facing analytics and dashboards. The launch adds a long-awaited feature for US users that’s been available for some time in Europe: users will be able to scan their sensors with an app on their smartphone — and see their latest reading — rather than requiring a separate, proprietary handheld reader (although the reader will still be an option for those that prefer it).This was shortly followed by news that Novo Nordisk has struck a deal with Flex Digital Health, part of the IoT logistics company Flex, formerly known as Flextronics. The company also just received Expedited Access Pathway designation from the FDA for a version of the program to treat opioid use disorder.More recently on November 13, the FDA approved Otsuka’s Abilify MyCite, which incorporates Proteus’ ingestion sensor into a drug for treating schizophrenia, bipolar disorder, and depression. Proteus and Otsuka jointly publicized Abilify MyCite as the first FDA approval of a digital medicine systemThese landmarks are undoubtedly transformational in the field of digital health, but with so many announcements of FDA approvals and clearances over the past few years, some are raising questions about what’s really first. Patients will need a valid prescription from their licensed provider in order to access the therapeutic. By Nick Haluck, Director at Health Advances It has been an exciting couple of months for digital therapeutics. It was industry itself that made the FDA aware of the need for a revamped process that addresses digital therapeutics and the new technologies they incorporate. Prescription digital therapeutics are scientifically validated and FDA-cleared digital interventions prescribed by physicians to treat medical conditions as first-line or adjuvant therapies. Depression is the most common co-occurring disorder with insomnia. The 12-week program is used in conjunction with standard outpatient treatment related to stimulants, cannabis, cocaine, and alcohol. Prescription digital therapeutics are clinically validated, FDA-cleared software applications that demonstrate safety and efficacy in randomized clinical trials to improve patient outcomes. Click to email this to a friend (Opens in new window)Beyond Traditional Drug Development: Leveraging Personalized MedicinePART 1: Reflections on 2017 – Biopharma Therapeutics FDA Responds to the Evolving Nature of Digital Health.

The therapeutic employs cognitive behavioral therapy (CBT) to help outpatients living with OUD. Patients and clinicians are our partners in developing programs that are highly effective and engaging so that it is easier for patients to stick with them. One of the new technologies uses Microsoft’s Azure App Services and will be able to send patient data to healthcare teams and first-line clinicians, alerting the them when there is a patient safety threat, according to the company.

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