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February 12, 2025 20 mins

Unlike general health and wellness apps, Prescription Digital Therapeutics (PDTs) are FDA-authorized, prescribed by healthcare professionals, and rigorously studied in clinical trials. With the global PDT market projected to reach $43 billion by 2032, new regulatory pathways, including CMS billing codes in 2025, are set to enhance adoption and accessibility.

In his final episode hosting the Syneos Health Podcast, Nick Kenny is joined by Dr. Shaheen Lakhan, Chief Medical Officer, and Laura Taraboanta, Director of Medical Operations and Strategy, both from Click Therapeutics, to explore the evolving landscape of PDTs.

Together, they discuss how PDTs work and for which conditions, the opportunities driven by the FDA’s Prescription Drug Use-Related Software (PDURS) guidance—which now enables PDTs to be integrated into drug labels, where PDTs are making inroads to expand access to care, and a future that will include “software enhanced” (SE) drugs that improve adherence, personalization and treatment outcomes.

The discussion underscores how PDTs are redefining personalized medicine, transforming healthcare delivery, and expanding into new therapeutic areas beyond mental health.

For more from Click Therapeutics and our experts on Digital Therapeutics, check out:

Syneos Health Podcast | Digital Therapeutic Commercialization

Syneos Health Podcast | Digital Therapeutic Development and Approval

10 Ways to Optimize and Accelerate Brand Performance using Prescription DTx

How Digital Therapeutics Developers Can Satisfy Diverse Stakeholder Needs

About Click SE™

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub.

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