Establishing Pharmaceutical-Grade Evidence for Novel Prescription Digital Therapeutics in Major Depressive Disorder

1. Background and Mission

Software as prescription medical treatments is developed, validated, and commercialized for people with unmet medical needs. Products include options for smoking cessation and for major depressive disorder.

2. The Opportunity

Amid a shortage of mental health providers, 21 million US adults had at least one major depressive episode, yet few evidence-based solutions without side effects exist. Interest existed to create a novel digital therapeutic for the treatment of major depressive disorder symptoms as an adjunct to clinician-managed outpatient care.

3. The Challenge

Effectively gathering strong evidence for market readiness and validating the efficacy of combined cognitive-emotional training exercises and therapeutic lessons is challenging. Certain payers perceive digital therapeutic products as inferior to standard care such as drugs, largely due to shorter development timelines, quicker regulatory authorization processes, and different requirements for safety and efficacy testing. This often results in skepticism about the quality of evidence. As a result, US payers are increasingly insisting on a higher standard of evidence for digital therapeutics, akin to that required for pharmaceuticals.

4. The Approach

As evidence was developed, engagement occurred with the FDA to understand the evidence requirements necessary for safety and clinical performance. Meeting pharmaceutical-level evidence requirements was crucial to combat market skepticism, gain credibility, and secure acceptance in healthcare. The approach mirrored a drug perspective, demonstrating regulatory nimbleness in overseeing innovative treatments. Utilizing pre-submission meetings, requirements and specifications were identified that were tailored to the product's distinctive capabilities in major depressive disorder for the 510(k) regulatory pathway.

5. The Success

A non-traditional approach was taken in developing this product, reminiscent of a drug company's style, especially with new regulatory developments in prescription drug use-related software. The FDA process was navigated through a methodology akin to that used for drug approval, demonstrating both evidence rigor and market innovation. A novel commercial model was utilized to pair the product with a leading antidepressant medication, with no treatment-related adverse events reported. Ninety-six percent of psychiatrists polled said adding exclusive brain training to the digital therapeutic could improve outcomes to a different extent than cognitive behavioral therapy alone. Oversight by regulatory agencies is crucial for developing novel treatments for diseases. The therapeutics are designed to achieve clinically meaningful results by altering brain circuitry through targeted digital interventions. Results are validated with rigorous clinical studies and involvement of prescribing clinicians is prioritized to ensure patients receive high-quality care. This approach provides the credibility that payers, providers, and patients need to trust and integrate new treatments.