The Digital Pill
Comprises a generic or branded drug with a personalized digital system for improving the response to chronic medications and reducing side effects.
The user-friendly app regulates treatment by introducing variability into dosing and times of administration within the approved therapeutic range.
Maximizes drug effectiveness decreases costs and improves outcomes.
The need to overcome loss of effect of chronic drugs
• Fixed dosing regimens of chronic medications lead to adaptation and drug resistance.
Non-responsiveness leads to non-compliance.
• Decreasing effect leads to increasing dosage and side-effects
• The burden of chronic therapies for patients with common chronic diseases is a major burden on health care providers (>3 trillion per year in the US).
The Digital Pill: Drug administration controlled by an app
Overcoming drug resistance & saving on admissions and expensive therapies
Overcomes drug resistance of cancers
Improves response to anti-TNFs in immune diseases
Overcomes resistance to anti-epileptics occurring in 30% of patients
Overcomes resistance to anti-depressants
Improves tolerance to analgesics: lowers the required dosages and reduces side effects
Improves the effect of diuretics in congestive heart failure
Regulatory Path
An FDA exempt “no claim”-based digital app: a reminder
Draft Guidance for Industry and Food and Drug Administration Staff September 27, 2019
Advantages for health system users and providers
Saving costs on admissions and expensive interventions in chronic diseases.
Improving patients' health and decreasing the costs of drugs.
A better physicians' experience.
Improving response rates leads to increased revenue for drug manufacturers.
