A new class of prescription digital therapeutics known as Software-Enhanced Drug (Click SE) treatments has been introduced by Click Therapeutics, a pioneer in the development of Digital Therapeutics. These solutions combine pharmacology with Click's own, AI-enabled digital therapeutic technology to improve patient outcomes and medication efficacy. This initiative aligns with the recent U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS), which emphasizes the importance of demonstrating clinically meaningful benefits through software-drug combinations. With Click SE, pharmaceutical companies can develop tailored “smart” therapies designed to improve treatment adherence, manage side effects, and deliver personalized interventions for patients.
Building on its leadership in digital therapeutics, Click Therapeutics aims to set a new standard in healthcare with rigorous clinical validation for its software-enhanced drugs. Recent success with CT-132, a digital therapeutic for migraine prevention, demonstrated a significant reduction in monthly migraine days when used alongside traditional pharmacotherapy. Click SE leverages similar clinical rigor, ensuring measurable benefits in various therapeutic areas such as neurology, psychiatry, and cardiometabolic diseases. According to company executives, this transformative approach could revolutionize treatment pipelines, enabling physicians to prescribe tailored “SE” versions of medications to improve patient care while advancing the integration of software and pharmacological treatments.
