What are digital therapeutics?

Digital therapeutics (DTx) has rapidly become one of the most exciting and innovative areas of healthcare, as this new technology is being leveraged to help treat an ever-growing array of health conditions.

This article will cover the following topics in relation to DTx:

Defining DTx
Areas of applications
DTx products currently available

By exploring the possibilities of DTx, this article will provide insight into how this emerging field can have a positive impact on patient outcomes.

What are DTx?

The FDA defines DTx as software designed to cause evidence-based therapeutic intervention in the prevention, management or treatment of diseases or medical disorders.

The software is then responsible for providing the intervention to the patient via a technology platform (app) or medical/pharmaceutical device. It also provides capability for real-time feedback for clinicians.

Most importantly, DTx must be clinically approved based on clinical trials published in peer-reviewed journals, demonstrating clinically meaningful outcomes. The clinical evidence and real-world outcomes are the threshold that separates DTx from digital medicine and digital health.

It's important to understand the difference between a wearable and a DTx. Wearables are physical products that provide insight into activity levels and physiological state, but don't make any claims of actually improving health. This means they are not regulated by health authorities such as the FDA. On the other hand, DTx are software serving as medical devices that can be used to change and alter behaviors. They have been designed to be effective tools for making modifications in lifestyle choices and correcting harmful habits. Furthermore, these solutions have been evaluated and approved by the relevant government bodies – providing assurance of their safety and efficacy.

Wearables are currently more popular, but digital therapeutics are gaining greater awareness and adoption. According to a recent survey of US physicians conducted by Bryter, 52% reported having used or recommended sensors and/or wearable devices to their patients, while 16% reported having used or recommended DTx.

Areas of applications

DTx has the potential to revolutionize healthcare in numerous ways, though one of its most noteworthy applications is its ability to alter and change patient behavior. Through this mechanism, DTx can be used to correct harmful habits, treat behavioral disorders and encourage positive lifestyle changes.

The FDA has approved more than 40 Prescription DTx since Pear Therapeutics obtained the first approval in 2017. They address a variety of disorders known to be impacted by behavior modification:

Substance use disorder
Chronic insomnia
Posttraumatic stress disorder (PTSD)–driven traumatic nightmares
Attention deficit hyperactivity disorder
Irritable bowel syndrome (IBS)
Reduction of pain in patients (18 years and over) with chronic lower back pain (indication)
Amblyopia in children aged 4 to 7 years
Abdominal pain associated with IBS in adults

Current examples

As we have seen, DTx has huge potential to help manage and treat various conditions. In this section we will take a look at several products currently on the marketed approved by the FDA to treat certain diseases.

ADHD

Developed by Akili Interactive, Endeavour Rx is an award-winning DTx designed to improve Cognitive Control functions in children with ADHD. Through a series of fun and engaging levels and activities, the game helps to enhance cognitive abilities such as working memory, sustained attention, and impulsivity control. Effortlessly combining entertainment with engagement and training, Endeavour Rx is a great example of using video game technology for clinical use. The game has been clinically proven to produce positive behavioral change in children with ADHD – making it one of the most impactful digital therapeutics available today.

Insomnia, opioid addiction and substance use disorder

Pear Therapeutics is a leader in the world of digital therapeutics, and they have received FDA approval for a number of their DTx solutions. The foundation for all their products consists of a 12-week cognitive behavioral therapy plan customized to the need of each individual.

Their products include:

Somryst, the first prescription digital therapeutic for treating insomnia. The program consists of three parts – relaxation therapies, education about healthy sleep habits and cognitive tools for managing stressors. Somryst also allows users to track their progress over the course of the program, so they can monitor their improvement as well as any setbacks or regressions.

reSET-O, the only FDA-approved DTx for opioid addiction. reSET-O has been clinically proven to reduce cravings and increase abstinence rates amongst those suffering from opioid use disorder. The interactive platform allows users to track progress on their recovery journey, with personalized milestones that help patients build a healthier lifestyle.

reSET, for substance use disorder (SUD). Structured similarly to reSET-O, but targeted to those suffering from SUD.

Chronic lower back pain

RelieVRx, an FDA-approved DTx that uses virtual reality to help patients manage chronic lower back pain via non-pharmacological means and in the comfort of their own homes. The program consists of 8 weeks of interactive and immersive virtual sessions.

RelieVRx is the first of its kind and utilizes immersive, interactive scenes to help reduce pain and increase relaxation. The VR therapeutic works by immersing the patient in carefully designed scenarios that encourage deep breathing, mindfulness, stretching and relaxation techniques. The scenes also provide educational topics related to managing stress, living with chronic pain and improving physical health. RelieVRx is set to revolutionize the treatment of chronic low back pain.

Irritable bowel syndrome (IBS)

Parallel™, developed by Mahana Therapeutics in collaboration with King's College London, is approved for use in both the US and UK (with accompanying CE marking for the latter). It is a prescription-only DTx designed to reduce the severity of IBS symptoms in adult patients. The program works by teaching users CBT skills to influence gut-brain communication and has been clinically proven to reduce IBS symptoms.

Digital therapeutics is a rapidly emerging field due to advances in AI, smartphone technology and increased connectivity with devices. Major tech companies see the potential to compete with pharma and seize market share. Furthermore, the emergence of COVID-19 has ushered in an era of wider acceptance of tech-enabled health solutions, such as telehealth visits, which have nearly doubled since pre-pandemic. Patients are now more comfortable engaging in healthcare from outside of traditional physical offices.

What's more, digital therapeutics are becoming more affordable and accessible as technology advances. This is good news for both patients and payers. For patients, it means they can get the treatment they need without breaking the bank. And payers see DTx as part of technological solutions to reducing the overall cost of health service provision.

About Bryter and digital pharmaceutics

Bryter is an international market research and insights consultancy specialising in pharmaceutical research. We work with leading manufacturers and service providers to better understand the role pharma plays in people’s lives, enabling them to develop & market their products and services more effectively.

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