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Key Background Information on Prescription Digital Therapeutics
Panelists discuss how prescription digital therapeutics differ from traditional pharmaceuticals by following FDA medical device approval pathways focused on clinical performance and safety rather than chemistry and manufacturing while offering potential economic value by extending behavioral health capacity to underserved populations, especially in rural areas with limited mental health professionals.
EP: 1.Discussing Negative Symptoms of Schizophrenia
EP: 2.The Clinical Burden of Negative Symptoms
EP: 3.Exploring the Shortage of Psychiatrists
EP: 4.The Potential of Prescription Drug Therapeutics (PDTs) in Schizophrenia
EP: 5.The Role of PDTs in Clinical Practice
EP: 6.Examining the CONVOKE Clinical Trial
EP: 7.The Future of Pharmacotherapy Plus PDTs
EP: 8.Economic Burden Associated With Schizophrenia
EP: 9.Key Background Information on Prescription Digital Therapeutics
Prescription digital therapeutics (PDTs) represent software-based, evidence-generating treatments that the FDA clears or authorizes as medical devices, specifically software as medical devices. These innovative treatments deliver therapeutic content such as cognitive behavioral therapy and can even diagnose certain disease states. Unlike traditional pharmaceuticals, PDTs follow regulatory pathways including de novo or 510K device routes rather than the standard NDA/BLA drug approval process, focusing on clinical performance, safety, human factors, and cybersecurity rather than chemistry, manufacturing, and controls.
PDTs offer significant economic value for patients with mental health disorders, particularly in areas with limited access to mental health professionals. With only about 20% of rural America having access to behavioral health services, these digital solutions can extend health care capacity by delivering repeatable, guideline-based care elements to populations who otherwise lack access. This capability addresses the growing clinical workforce shortage in behavioral health, which has become more severe than originally projected 2 decades ago.
These digital therapeutics provide unique advantages by bringing treatment directly to patients who may struggle with transportation barriers, lodging challenges, or motivation to travel for care—issues particularly relevant for patients experiencing negative symptoms of mental health conditions. PDTs can shift routine care elements to digital platforms while preserving human clinical resources for more complex interventions, making them valuable tools for extending care reach in both metropolitan and rural settings where traditional mental health services remain inadequately available.
