FDA’s New Prescription Drug Use-Related Software Guidance Validates the Value of a Rigorous Approach to Developing Prescription Digital Therapeutics
By David Benshoof Klein
Founder and CEO
09.27.2023
PDURSClick SEWhere science meets software.
Software as treatment. Delivered to your phone. Prescribed by your physician.
Click Therapeutics is redefining modern medicine with patient-centric digital treatments. Operating at the intersection of biology and technology, Click combines neuroscience with the power of software, creating a new way to treat disease.
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We develop, validate, and commercialize software as prescription medical treatments for people with unmet medical needs.
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Click SE™ solutions combine software with pharmacotherapy to create software-enhanced drug™ treatments, to deliver added clinical benefit to patients compared to drug alone.
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Our multimodal, platform-based approach targets disease and drives outcomes from multiple different angles, combining scientifically proven therapies with proprietary neuromodulatory mechanisms of action to deliver clinically-meaningful interventions.
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- PDTs deliver evidence-based treatments directly to a patient via their smartphone in the form of a mobile app. With PDTs, the software is the treatment. PDTs are prescribed by a physician to treat a disease or condition, and as such are clinically validated and FDA-regulated, much like a medicine. PDTs can be used independently or in combination with traditional pharmaceutical treatments.
- Click SE™ solutions offer a new approach to medicine, which combines software with pharmacotherapy to create software-enhanced drug™ treatments. We work with pharma to create “SE” (software-enhanced) formulations of their pipeline and marketed drugs that offer added clinical benefit. Click SE™ solutions build on Click’s proprietary AI-enabled platform and our deep experience developing regulated prescription digital therapeutic treatments with global pharmaceutical innovators.
- Software-enhanced drug™ therapies target the unique needs of a medication and patient population to deliver added clinical benefit. Compared to other PDURS solutions, these treatments are differentiated by a high level of clinical rigor and offer patients an engaging and personalized treatment experience to achieve superior clinical outcomes, which are measured in clinical studies with gold standard endpoints and listed in the drug label.
- In September 2023, the FDA released a new guidance document titled Regulatory Considerations for Prescription Drug Use-Related Software (PDURS). This guidance outlines how the FDA intends to apply its drug labeling authorities to software outputs associated with prescription drugs or drug-device combination products, covering a full spectrum of use cases. It provides clarity on when certain types of software can only be described in promotional labeling or when it is appropriate to include in the FDA-required labeling such as the package insert.
- FDA specifies that evidence of added clinically meaningful benefit from the use of software with a drug compared to use of the drug alone (from one or more adequate and well-controlled clinical studies) can be included in the drug label. To meet this standard and deliver maximal value of PDURS to patients, pharma can prioritize software that complies with the requirements for software-as-a-medical-device (SaMD), can withstand regulatory scrutiny in premarket authorization filings, and consistently offer best-in-class engagement and clinical outcomes.
- Click Therapeutics designs prescription digital therapeutics to deliver clinically meaningful benefits to patients. These therapeutic outcomes can be assessed by gold standard measures and can impact primary or secondary efficacy endpoints, safety, tolerability, or side effect management. For more information on how Click Therapeutics has demonstrated this benefit, see data from Click’s preventive migraine investigational prescription digital therapeutic here.
- Click Therapeutics utilizes market and user research to develop prescription digital therapeutics that meet the needs of patients, providers and payers, ensuring maximal value delivery for the health system, whether offered independently or in combination with medication. Software-enhanced drug™ solutions can offer additional value by differentiating biomedical treatments in competitive therapeutic areas and extending franchise value with ongoing, iterative software releases that add new benefit for patients over time.
- By introducing a new “SE” formulation, a pharma manufacturer can create a new treatment with a unique efficacy and safety profile, enabled by the proprietary software-based technologies and methods included in the digital therapeutic component of the treatment. This SE formulation - because it is digital - can be improved over time, yielding improved patient benefit as well as new intellectual property via novel R&D, technology platform improvements and real world learnings.