The digital therapeutics market has surged during the pandemic and looks likely to markedly change health care long after the current crisis abates. The need for distance, limited in-person appointments, increased stress and mental health issues, and a more relaxed U.S. FDA approach have created the ideal environment for the rollout of therapies patients can use from home on their own time. Increasingly, clinical trials demonstrate the effectiveness of the new options and users praise the convenience.

In response to this rapidly evolving environment, Uppsala, Sweden-based Orexo AB quickly brought several apps to the U.S. market, while San Francisco-based Big Health continues to report good news regarding its digital therapeutics. Other companies, including Pear Therapeutics, Click Therapeutics, and Mahana Therapeutics, have also released a number of new apps.

The FDA designed the Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders during the COVID-19 Public Health Emergency issued in April 2020 to “expand the availability of digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19.” The agency anticipated digital therapeutics would aid in treatment of a number of symptoms and disorders including depression, alcohol use disorder, anxiety, insomnia, suicidality, autism, attention deficit hyperactivity disorder, obsessive compulsive disorder and post-traumatic stress disorder.

The less stringent rules allowed rapid rollout of a number of applications, just as the mental health impact of stay-at-home orders, economic disruption, and pandemic anxiety drove the rates of individuals reporting mental or behavioral health issues to new heights. In August, the U.S. CDC reported that more than 40% of Americans said they struggled with issues such as anxiety, depression, increased substance use, and suicidal thoughts in connection with COVID-19. “Markedly elevated prevalences of reported adverse mental and behavioral health conditions associated with the COVID-19 pandemic highlight the broad impact of the pandemic and the need to prevent and treat these conditions,” the CDC noted.

Orexo enters U.S. market

Orexo entered the market just in time to respond to increased demand for remote or patient-controlled delivery of mental health support. “To meet the growing need of digital therapies raised by COVID-19, Orexo accelerated the launch of the scientifically proven digital therapies Deprexis and Vorvida,” said Dennis Urbaniak, Orexo’s executive vice president digital therapeutics. Deprexis, an adjunctive therapy for people with depression, launched in the U.S. on July 1, 2020 and Vorvida, designed for individuals who want to reduce their alcohol use, followed on July 15, 2020. Orexo expects to introduce a third app, Modia, which will address opioid addiction, in 2021.

Deprexis requires a health care provider’s oversight and initial order to begin therapy. Vorvida, in contrast, is available to individuals with or without physician involvement. Both self-directed programs require no direct monitoring, although the company encourages people using Deprexis to discuss their progress with a health care provider.

Vorvida takes an unusual approach to excessive alcohol use by focusing on reducing intake rather than eliminating it entirely. “Currently, options for problematic and harmful alcohol use are binary and absolute, without middle ground,” Urbaniak told BioWorld. “Abstinence can fail to address the unique circumstances of each person who overuses alcohol. Vorvida allows the individual to set their own goals for their drinking behavior going forward, which may or may not be abstinence.”

The novel program received significant support from a randomized clinical trial involving 608 adults with problematic alcohol intake. Most participants exhibited binge drinking behavior 15 to 16 days per month on average. Individuals in the intervention group using Vorvida reported a significant reduction in daily alcohol consumption over three and six months and fewer days of binge drinking and drunkenness compared to those in the control arm, Urbaniak said.

Vorvida uses an artificial intelligence system, Broca, to learn about the user and understand the social, environmental and psychological triggers that lead them to consume alcohol excessively. It then applies what it has learned about the individual to customize the cognitive behavioral therapy (CBT)-based exercises central to the program to help users acquire new skills that enable them to respond in a more positive manner to these stimuli and form new, healthier habits and behaviors.

Deprexis and Modia, like many other recently released digital therapies, also uses CBT-based tools and techniques. Orexo licensed all three apps and the underlying AI from their developer, Gaia, a digital therapeutics research and development company based in Hamburg, Germany.

Modia will be tested with select U.S. customers early in 2021. Orexo plans a broad launch in the third quarter, a year ahead of the original plan, according to Urbaniak.

Big Health

Another significant player in the digital therapeutic market, Big Health, recently reported that a study published in Sleep found that its digital CBT for insomnia, Sleepio, is the most effective treatment for poor sleep, beating out drug therapy as well as group and individual CBT.

The study used a Markov simulation to determine the cost effectiveness of digital CBT over a six-month period in 100,000 individuals in the U.S. The study included both direct and indirect costs of insomnia, such as health care expenditures, workplace accident risk and lost productivity. Using Sleepio yielded a net positive financial benefit of $681.06 per individual over six months compared to no treatment and was more effective than group CBT, which had a financial benefit of $647.24, pharmacotherapy, with a benefit of $273.15, and individual CBT, which had a financial benefit of just $74.73, according to the model. Sleepio demonstrated a positive net monetary benefit in 94.7% of the simulations.

Big Health adopted a novel distribution model for Sleepio, making it available through employers as a covered benefit. It does not require a prescription and cannot be accessed by individuals directly. “Early in the pandemic, we made our programs available for free to employers to help with the overwhelming need for remote mental health solutions,” Jenna Carl, Big Health’s vice president for clinical development and medical affairs told BioWorld.

Big Health also offers Daylight, a digital therapeutic for anxiety. Neither requires a prescription, making them more readily and privately available, overcoming common issues of access and stigma that often limit use of mental health services.

Those issues will remain even after the pandemic passes, increasing the likelihood that more people will use a wider variety of digital therapeutics in the future. As Carl noted, “the hope then is that digital therapeutics makes evidence-based mental health care accessible to the whole population for the first time in history, and even provides a number of additional benefits and conveniences such as being accessible 24/7, personalized and destigmatized.”