Digital Therapeutics Might Address Gaps in Care for Mental Health Patients

In a session at the American Association of Psychiatric Pharmacists Conference 2024, Kari Franson, PharmD, PhD, BCPP, senior associate dean for Academic and Student Affairs and professor of Clinical Pharmacy at the University of Southern California, discussed the potential of prescription drug therapeutics (PDT) for mental health disorders.

“Digital medicine are technologies that broadly support clinical practice. Software as a medical device is an area that actually can include digital therapeutics, in this idea that some software can be use as diagnostic,” Franson said in the session. “But also, this would include our digital therapeutics if it’s going to prevent, manage, or actually treat a specific disease.”

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PDT undergo approval through either the De Novo or 510(k) approval pathways at the FDA. The FDA is looking at the therapeutic’s effect on the disease, the possibility of adverse events (AEs), and the efficacy on the disease state. De Novo pathways include technology that are more novel and have not been tried or evaluated before, and 510(k) focuses more on the efficacy of a therapeutic if it operates in a similar mechanism as something that has already been approved.

The FDA evaluates the application’s usability, including operating platform and the software or hardware interactions, making sure it is optimized for usage. Further, they evaluate for the transparency of the input, output, and methods for both patient and physicians so that the correct decisions are being made based on the information provided. The FDA will also be looking at the fragility of the disease state. For example, therapeutics involved in suicidal ideology would be carefully considered due to the severity of the disease state. Finally, the clinical evidence and benefit of the device are evaluated.

“Digital technologies can be utilized to really address the large difficult things that we have in mental health—the access to good new psychotherapy, addressing symptoms that have been creating resistance to our pharmacotherapy,” Franson said. “There are things that we need to be doing . . . because we can do better.”

Franson discussed some of the PDT devices that are available, including reSET and reSET-o, which are for substance use disorder and opioid use disorder, respectively. reSET was the first PDT approved in the United States and has 61 interactive modules with community reinforcement approach lessons, fluency training, and contingency management through various rewards. In a study of the software, individuals in the reSET group had a greater abstinence rate than those in the treatment as usual group, especially among those who had positive urine drug or breath alcohol screening at the study entry. In a real-world analysis, individuals who had SUD related to alcohol, cannabis, cocaine, or other stimulants also had higher abstinence and retention, with no significant differences AEs, according to Franson. For opioid use disorder (OUD), 91% of patients met the responder definition of 80% of self-report or urine drug screen negative. For a second prescription of reSET-O, there was a 27% decrease in unique hospital encounters compared to those who only had a single 12-week prescription.

Another software that Franson discussed was EndeavorRx and EndeavorRxOTC. EndeavorRx is a game-based software for attention-deficit/hyperactivity disorder in children aged 8 to 12. Patients play the game at home for 25 minutes, 5 days per week, for 4 weeks. It was found that the software improved attention and cognitive control, although 18% experienced mild to moderate AEs, with the most common being frustration tolerance, according to Franson. Furthermore, the software was also studied in children aged 8 to 14 years who were taking stimulants. There were improvements in ADHD-related impairments after 4 weeks, with AEs that included frustration, headache, dizziness, emotional reaction, nausea, and aggression.

EndeavorRxOTC was created for adults with ADHD, but instead of being prescription-based, it was available OTC. Investigators found even higher improvements for adults compared to pediatric cohorts, according to Franson, and it is available for $24.99.

There are also several devices created for posttraumatic stress disorder (PTSD), including NightWare and Freespira. NightWare is an Apple Watch app used to manage nightmares associated with the trauma, working by delivering a brief vibration to interrupt the nightmare without waking the patient. However, patients have reported ineffective treatment, so the company is testing and reevaluating the system’s clinical performance, according to Franson.

Freespira works through cognitive behavioral therapy and monitoring of biofeedback via exhaled carbon dioxide levels and respiratory rates to train patients how to manage stress and anxiety. Patients who used the product for 4 weeks demonstrated a decrease in recording of PTSD scale over time, with maintained benefits after treatment.

Franson also discussed Somryst for insomnia, which demonstrated that 40.6% of individuals who used it were reduced below the threshold of having chronic insomnia. Further, the treatment effects were maintained at the 1-year follow up. Patients had greater control, including falling asleep faster and staying asleep longer.

For major depressive disorder, Rejoyn is an adjunct for antidepressant medications that was recently approved on April 1, 2024. It includes cognitive behavioral therapy lessons and emotional faces and memory tasks to help patients rethink their responses to cues in their environment, according to Franson.

There are also many emerging therapeutics. One example is CT-155 for negative symptoms of schizophrenia, which demonstrated a 17% reduction in experiential negative symptoms at 7 weeks.

Franson said that pharmacists play a large role in discussions of PDT, so they should be educated on these devices compared to available medication.

“By having data, we can get patients better faster, and I always think about [how] we get patients better faster in the hospital than we do on an outpatient. That's only because we're worried about starting low and going slow and the risks,” Franson said in the session. “What if we have data that are able to manage those risks?”

Additionally, pharmacists should tell patients to read the reviews on the apps because that could help them learn from peers whether that tool could work for them. Further, but most importantly, Franson said that payers do not cover these prescriptions for use, so it will be costly for patients who want to use this software.

References

Franson K. A New Script: Implementing Prescription Digital Therapeutics into Practice. American Association of Psychiatric Pharmacists Conference 2024; Orlando, Florida; April 7-10, 2024.