A Target Product Profile Framework to Guide Patient-Centered Development, Regulatory Approval, and Market Access of Digital Therapeutics for Substance Use Disorders.

Background: Digital therapeutics (DTx) offer a scalable means of addressing persistent barriers to substance use disorder (SUD) care, including stigma, provider shortages, and geographic inaccessibility. SUD was the first therapeutic area in which the U.S. Food and Drug Administration (FDA) authorized a prescription DTx, establishing the regulatory classification under which a growing family of DTx has since reached the market. First-generation SUD DTx demonstrated clinical efficacy, opened regulatory and reimbursement pathways, and generated an empirical account of what successful translation requires beyond FDA authorization, namely, sustained engagement, clinical workflow integration, payer-aligned evidence, and affordability. Objective: The Target Product Profile (TPP), a planning framework long used in drug and vaccine development to align product design with regulatory, clinical, and market requirements from the outset, offers a practical mechanism for converting these lessons into prospective design decisions. Yet no TPP has been published for a DTx for SUD, and TPP development for therapeutic DTx remains fragmented, limited to general templates and isolated examples. As most companies do not publish their TPPs, our goal is to posit a working, public framework to guide developers. Methods: In this review, we synthesize FDA authorization summaries, regulatory guidance, implementation experience, and market-access literature to derive an evidence-informed TPP for SUD DTx, using opioid use disorder as an illustrative case. Findings and Conclusions: We specify minimum acceptable and ideal target profiles across eleven attributes and discuss how academic investigators and small businesses, already primary drivers of published TPP development, can use this framework to design DTx that reach the patients who need them.