World first digital pill gets FDA green light

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Otsuka (in association with Proteus Digital Health) has been granted approval by the US FDA for Abilify MyCite, the world’s first digital pill, which contains a sensor that tracks when the medicine has been ingested by the patient. Though Abilify is an Rx medicine for schizophrenia and bipolar disorder, its approval has far-reaching implications for both prescription drugs and consumer healthcare.

How it works: Containing a sensor the size of a grain of sand, Abilify MyCite emits an electrical signal when it comes into contact with stomach acid, and this signal is received by a patch on the patient’s rib cage. In turn, this patch communicates with a smartphone app via Bluetooth, providing data such as time of ingestion and dosage. As well as the doctor and patient, up to 4 other people (including family members) can have access to the app’s data – though, importantly, the patient has control and can revoke access.

 

Mitchell Mathis, Director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation & Research, said: “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.” Inevitably, during the initial phase, the digital pill will be incorporated solely into Rx medicines – to allow the FDA to monitor its impact on safety and adherence – however, at a later date, there is nothing to stop this new technology being part of innovative Rx-to-OTC switches.

Patients, doctors and insurers are increasingly coming to appreciate the ability to access objective data about the whole range of our medical consumption – from Rx drugs to OTCs and supplements. Once the price of these new sensors is reduced to a certain level of affordability, we could see a much wider rollout of the technology.

That said, a major stumbling block could be the issue of privacy. Some are concerned that patients who fail to take their medicines on a regular basis may be punished by their health insurers, while others have worries that the technology could be used as a coercive tool against certain types of patients. However, those concerns aside, the future for healthcare looks increasingly digital and the FDA is already hiring more staff in anticipation of a raft of new applications for digital pills.

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Hollywog unveils smartphone-controlled pain device

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As revealed by our recently published MAT Q2 2017 info, global sales of topical analgesics (+8.2%) fast outpaced systemic analgesics (+3.8%), owing to higher levels of product innovation. This trend was particularly noticeable in North America, where sales of topical analgesics were up 16.2% in the year to end-June 2017.

One specific area of dynamism has been topical pain relief devices, specifically TENS machines, with a variety of smaller marketers and established OTC players launching such products in recent years. For example, Bayer launched TENS device Aleve Direct Therapy in summer 2016.

The innovation stakes have now been raised higher with the launch of a smartphone-controlled TENS device by US marketer Hollywog. The WiTouch Pro Bluetooth TENS Therapy device is paired with the WiTouch Pro App to provide stimulation pain therapy to the lower back.

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According to Chuck Thomas, CEO of Hollywog: “This launch signals an important innovation for Hollywog, where our new patented pain management solution, the WiTouch Pro, offers a drug-free digitally-enabled alternative to block pain and keep moving. People are looking for a discrete solution that is personalised for their pain and with this launch we deliver on that need.”

This trend is likely to accelerate, with marketers like Purdue Pharma already looking at how to deliver pain therapy via smartwatches too.

Futuristic “smart bandages” can repair your body

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Bandage technology has gradually been revolutionised in the 100 years since Band-Aids were first introduced. Researchers from the University of Nebraska-Lincoln, Harvard Medical School and MIT are now ready to introduce the next century of wound care with the “smart bandage”.

The smart bandage has individual fibres that store medications which can be later implemented using a smartphone or another mobile device. The bandage is made up of electrically conductive fibres that are coated in a gel that can house medications. Antibiotics and painkillers can be used within the bandage, and possibly many other effective combinations that will enhance recovery.

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Individual fibres can then be activated via voltage from a connected micro-controller no larger than a post stamp using a connected mobile device. Ali Tamayol, Assistant Professor of Mechanical & Materials Engineering at Nebraska, explained: “This is the first bandage that is capable of dose-dependent drug release, you can release multiple drugs with different release profiles.”

This is an exciting platform that can potentially be applied to many different areas of biomedical engineering and medicine. Not only could it be useful for dealing with battlefield injuries, it could also help in the treatment of chronic wounds, which are common in patients living with diabetes.

This is not the only “next gen” bandage in development. A team from Swansea University’s Institute of Life Science has created bandages laden with nano-scale sensors that can instantaneously transmit health information to medical professionals using 5G wireless data.

Voice-activated tech shows potential for diabetes care

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Diabetes affects 422mn people worldwide, including 14% of the US adult population and people in low and middle-income countries such as China, India, Brazil and Indonesia. To successfully manage diabetes, people living with it need to be mindful of and track myriad things throughout their day, from blood sugar levels to counting calories. In recent years voice-activated technologies have become an important way of helping sufferers manage their disease.

In this regard, Danish pharmaceutical company, Novo Nordisk, has teamed up with Health Innovation Technology Lab (HITLAB) to launch the 2017 HITLAB World Cup of Voice-Activated Technology in Diabetes, awarding prizes totalling US$75,000.

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Participating innovators have been told to focus on enhancing patient outcomes, lowering healthcare costs and making the management of patients more efficient, with the goal of improving health and quality of life for diabetes sufferers.

Amy West, Senior Director, Patient Centric Marketing & Digital Health at Novo Nordisk commented: “We are constantly striving to provide solutions that minimise the burden for people living with diabetes, and believe that digital health, and specifically voice-activated technologies can be important tools for managing diabetes.”

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HITLAB has helped leading organisations create and evaluate technology-based solutions to pressing healthcare challenges for the past 25 years. Last year, 74 teams from 14 countries presented technology innovations that ranged from a tech-enabled dynamic scoliosis brace to a tool that uses 3D imaging and data analytics to better diagnose ear infections. Past winners have since raised over US$50mn in follow-on investment funding.

The submission period is currently open and will close on Wednesday 11th October. Finalists will be announced on 23rd October. They will make pitches at the HITLAB Innovators Summit, which will be held in New York City. Pitches will be judged by a panel of healthcare experts assigned by Novo Nordisk and HITLAB.

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

 

The future of diagnostic wearables?

 

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The University of Tokyo has recently started to develop a new generation of wearable diagnostics. The hypoallergenic electronic sensor wearables are designed to monitor health indicators without being invasive or causing any discomfort.

The electronic sensors are made up of breathable nanoscale meshes that attach directly to the skin to produce accurate and precise readings of heart rate and other health indicators. Japanese scientists believe the new wearables can be worn for up to one week, without causing any irritation. However, if devices are worn over a longer period it is thought they may be deemed unsafe, as they prevent breathability and block airflow causing irritation and inflammation.

“We learned that devices that can be worn for a week or longer for continuous monitoring were needed for practical use in medical and sports applications” says Professor Takao Someya at the University of Tokyo’s Graduate School of Engineering.

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The device can be applied by spraying a small amount of water, which dissolves PVA nanofibres to allow it to stick to the skin. It is designed to fit curvilinear surfaces of skin making it ideal to apply to sweat pores and index fingers.

Scientists are hopeful this is the beginning of a new chapter for wearable diagnostics and hope that it will be possible to measure health indicators without causing stress or discomfort to the user. The device is thought to not only be the future for medical diagnostics, but also have applications for sports technology.