FDA’s New Prescription Drug Use-Related Software Guidance Validates the Value of a Rigorous Approach to Developing Prescription Digital Therapeutics

The FDA released draft guidance this past week on the regulation of patient and prescriber-facing software for use with prescription drugs and biologics. It clearly states that when additional clinically meaningful benefit is demonstrated through this combination, the added benefit may be included on a drug’s label, in the package insert. This guidance is momentous; almost five years in the making, it lays out the Center for Drug Evaluation and Research’s (CDER) approach to regulating prescription drug use-related software, including software as a medical device (SaMD), and once finalized will confirm as guidance what was previously simply a policy proposal.

This announcement is also significant because it validates the approach to digital treatments that Click Therapeutics has long championed. Click creates and advocates for developing prescription digital therapeutics (PDTs) with biotech-like rigor through clinical validation and FDA regulation.

And importantly, this new guidance affirms that PDTs offer a unique value creation opportunity for pharma. It differentiates evidence-based products like PDTs, which will be included on a drug’s label, from companion apps, which FDA indicates should only be represented in marketing materials. As regulated SaMD, PDTs can be combined with pharmaceuticals to create combination products, offering a path forward to protect and capture market share by offering evidence of added patient benefit. This can directly build brand value by:

• Converting shelved assets into success stories
• Boosting efficacy and outcomes of treatments
• Targeting adjacent endpoints to drug targets
• Improving formulary positioning
• Expanding drug labels with additional indications or claims
• Differentiating assets in competitive markets or against generics
• Creating rich, longitudinal datasets optimized for AI/ML and population insights

This regulatory clarity brings us one step forward to the digitally-enabled patient journey of the future. In this future, it will be routine for patients to be considered for PDT therapy at the same time they are considered for pharmacotherapy. When a physician looks to prescribe a new statin or migraine medication, they will consider not only the typical dosages, e.g., 10mg or 20mg, but also PDT-enabled dosages, e.g., e-10mg or e-20mg, with the benefits of the e-dosage clearly described in the drug label. We are now one step closer to creating that future.?

Of course, for this future to succeed, PDTs need to routinely deliver evidence of clinically meaningful benefit. The first generation of digital therapeutics offered a translation of cognitive behavioral therapy (CBT) into a digital format. This initial generation of treatments indeed demonstrated efficacy on quality of life and functional endpoints, often in smaller academic studies.

The approach that Click Therapeutics advocates for and adheres to - what we call PDT 2.0 - has moved beyond that approach by delivering sophisticated, multimodal treatments designed to modulate neurological pathways for sustainable, clinically meaningful change. In comparison with a typical health app or previous versions of digital therapies, PDT 2.0 treatments are evidence-based, high quality treatments using standards akin to biotherapeutics to achieve drug-like efficacy and adoption. This means they undergo drug-like refinement, testing and FDA review, are distributed through drug-like prescribing and under physician oversight, and deserve drug-like reimbursement.?

It is these qualities of this next generation of PDTs that make them perfectly suited for development as combination therapies with drugs under this new Guidance.

Now is the time to realize the value that this opportunity presents. At Click Therapeutics, we firmly believe that PDTs should be approached as new biotech assets, not just quick-to-market digital assets. It is only through that level of rigor and investment that the potential of PDTs will be achieved. Strategic partnerships are key, which is why I have shared that one of the biggest factors that will contribute to the adoption of PDTs is for pharma to become integrally involved in their development and commercialization.?

While the digital nature of Prescription Digital Therapeutics may seem novel and exciting, their success hinges on a commitment to the same standards that pharma excels at: rigorous development, high quality evidence, and a patient-centric approach. The FDA’s announcement reminds us that by treating PDTs as a new form of treatment and by following the same playbook as that used for any other new medicine, we can revolutionize healthcare for the better.?