Could PDURS Be the Game Changer to Unlock Digital Therapeutics?

Oct. 24, 2024

Whereas software had traditionally been used by patients to track and manage their disease, clinical evidence has demonstrated software can also be used to as a therapeutic to impact clinical outcomes. Prescription digital therapeutics (PDTs) are uniquely positioned to address some of the key shortcomings of traditional pharmaceutical-based treatments, including stigma, poor access to care, provider shortages, and the complexities of the healthcare system. Importantly, PDTs can also be utilized as a treatment in conjunction with traditional pharmaceuticals, without risking additional drug-related side effects or drug-drug interactions.

Click Therapeutics has been a standout in applying the same rigorous standards typically applied to pharmaceutical interventions to Click's trials for PDTs, which will be key to driving adoption over time. Recent FDA guidance on Prescription Drug Use-Related Software (PDURS) opens the door to a new treatment category combining digital and pharmacological interventions, and Click is focused on partnering with traditional pharma companies to unlock the value in combination treatments. To discuss this topic, I’m joined by Randall Stanicky, Click Therapeutics' CFO.

Chapters:
0:27 Introduction
1:05 Overview of Click Therapeutics and Digital Medicines
2:50 Positioning Click Therapeutics for Commercial Viability
4:55 Partnership Model with Traditional Pharma Manufacturers
6:55 Opportunities Across Various Disease Areas
8:10 Click's Recently Published Results for Migraine
10:15 Background of FDA's PDURS Draft Guidance
11:40 PDURS May Promote Traditional+Digital Drug Combos
15:05 How PDURS May Influence Digital Medicine Trial Design
16:20 PDURS May Increase Pharma's Interest in Digital Medicine
19:10 How PDURS Can Revitalize Digital Medicines Industry

This podcast was originally recorded on September 10, 2024.


Portrait of Charles Rhyee

Managing Director, Health Care - Health Care Technology Research Analyst, TD Cowen

Portrait of Charles Rhyee


Managing Director, Health Care - Health Care Technology Research Analyst, TD Cowen

Portrait of Charles Rhyee


Managing Director, Health Care - Health Care Technology Research Analyst, TD Cowen

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