J&J, Sandoz seek digital health breakthroughs

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Two stories we picked up this past week involve key OTC marketers, J&J and Sandoz (Novartis), and new digital healthcare initiatives. J&J subsidiary Janssen announced it is collaborating with Apple by conducting a multi-year research study investigating whether the Apple Watch can detect the onset of a stroke.

The study, due to begin later this year and tracking people aged 65+, will explore whether using a medication adherence app from J&J, in combination with Apple Watch’s ECG app, helps to accelerate diagnosis of atrial fibrillation (AFib) and improve healthcare outcomes, including the prevention of stroke. Paul Stoffels, J&J’s Chief Scientific Officer, also said: “Based on the insights generated through this research programme, we may be able to develop new ways to detect other health conditions earlier in the future that also exhibit measurable physiological symptoms.”

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Sandoz has also just announced the three finalists for its second Sandoz Healthcare Access Challenge (HACk). After receiving 400 digital technology submissions from 80 countries, Sandoz narrowed the finalists down to entries from Uganda, the Netherlands and the USA. Finalists take part in a 4-day “accelerator event” in Austin, Texas in March 2019, working with Sandoz to refine their ideas into scalable solutions ahead of final judging. The three finalists are as follows:

  1. Uganda: The Mobile Clinic plans to develop an app that can be used to make emergency appointments via a toll-free number and will be directly linked to a mobile van clinic offering door-to-door services in rural areas.
  2. USA: Regulora is in development as a prescription-only digital therapeutic for IBS based on Gut Directed Hypnotherapy. The mobile app connects patients with automated digital therapy sessions from the comfort of their own home.
  3. Netherlands: Social Genomics is building an AI-based smart social network, enabling people with rare and undiagnosed diseases to connect and share stories, providing access to global real-world patient data insights about treatment options and scientific research.

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App Store trend of 2018: Self-care

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Apple’s distribution platform for mobile apps, the App Store, recently selected self-care as its trend of the year. Wellness apps designed to encourage healthy habits, improve sleep, reduce anxiety and increase mindfulness have been the major trend on the iOS platform over the past year, according to Apple.

Fittingly, one of these popular apps is called #SelfCare, launched by TRU LUV Media in summer 2018. Designed like a game, the app promotes emotional wellbeing via breathing exercises and other small acts of self-care. Another is called Shine – Self-Care & Meditation, which delivers free daily motivational messages, 5-minute affirmations and meditations, plus tips on how to reduce stress, improve sleep and increase focus.

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The popularity of such apps is good news for OTC marketers, especially those operating in lifestyle and VMS categories that focus on mental wellbeing, i.e. sedatives & sleep aids and herbal memory & brain health. Apple noted that apps for physical health, such as those that track calories and steps, have long been popular with iOS users, but emphasised that this trend towards apps for mental health is a new phenomenon.

That said, what may be somewhat concerning to OTC marketers is that this evolving definition of self-care doesn’t appear to include self-medication. While OTC New Products Tracker lists medical device launches in 2018 that incorporate an accompanying app – such as Nokia Sleep and Natural Cycles, the latter designed to aid conception – supplements or drugs backed by a mobile app are much thinner on the ground.

Review the latest new products hitting the CHC market with OTC New Products Tracker, the ideal competitive intelligence tool. We recently unveiled a major update, with eye-catching new graphs and powerful search filters that help you visualise and explore the vast archive according to your exact requirements. To trial the updated database or for a demo, please contact waisan.lee-gabell@NicholasHall.com

 

FDA permits marketing of first mobile medical app

USA’s Food & Drug Administration has permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). It is planned that the reSET application, to be marketed by Pear Therapeutics, will be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs but will not treat opioid dependence.

The reSET device was reviewed through the de novo premarket review pathway, a regulatory pathway for some low to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

Carlos Peña, Director of the Division of Neurological & Physical Medicine Devices at the FDA’s Centre for Devices & Radiological Health commented: “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment.” Peña continued, “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

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The reSET device is a mobile medical app containing a patient application and clinician dashboard. The device delivers cognitive behavioural therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programmes.

The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of reSET which could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used reSET (40.3%) compared to the patients who did not (17.6%).

The reSET device is indicated as a prescription-only adjunct treatment for patients with SUD who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or whose primary substance of abuse is not opioids.

Smartphone app may help older adults manage serious mental illness and chronic health conditions

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The use of new technologies in geriatric psychiatry shows promise for advancing personalised medicine and improving patient care. A new study in The American Journal of Geriatric Psychiatry describes the successful adaptation of an integrated medical and psychiatric self-management intervention to a smartphone application for middle-aged and older adults with serious mental illness.

Care of middle-aged and older patients with serious mental illness can be difficult. Often these patients suffer from other medical conditions and are at increased risk of premature death. In order to help patients cope with their illness, researchers from Dartmouth developed a smartphone-based intervention using adaptive systems engineering framework and principles of user-centred design.BJHC_elderlylady_mobile_mini_0_8

“The use of mobile health interventions by adults with serious mental illness is a promising approach that has been shown to be highly feasible and acceptable,” explained lead investigator Karen L. Fortuna, PhD, of the Dartmouth Centers for Health and Aging and the Geisel School of Medicine at Dartmouth.

They found that even patients with limited technical abilities could use this app successfully. The app and intervention protocol were developed using commercially available products from Wellframe.

Following multiple design iterations, investigators tested the app’s usability and found Ten participants with serious mental illness and other chronic health conditions reported a high level of usability and satisfaction with the smartphone application.

The app takes patients through 10 sessions over a period of around three months, covering topics such as stress vulnerability and illness, medication adherence and strategies, and substance and medication abuse. Physicians can remotely monitor app use, and intervene when problems are detected, facilitating telemedicine for less accessible populations.

This study is part of a special issue of The American Journal of Geriatric Psychiatry that captures an important moment in the evolving relationship between technology and the clinical care of