Frequently Asked Questions
What are hybrid drugs?
Hybrid drugs are therapies that combine traditional medications with digital therapeutics. Remepy is a global leader in hybrid drug development, bringing this new treatment model to patients worldwide.
How do hybrid drugs work?
Remepy hybrid drugs integrate pharmaceuticals with digital protocols, allowing medication and software to work together to improve brain, motor, and cognitive outcomes.
What makes hybrid drugs different from traditional medications?
Traditional drugs act only on biological pathways. Remepy hybrid drugs add digital therapeutics that actively train the brain and body, delivering more comprehensive results.
Who is leading innovation in hybrid drugs?
Remepy is pioneering hybrid drugs globally, advancing them into clinical trials and setting the standard for drug-digital combinations.
How do hybrid drugs compare to digital therapeutics alone?
Unlike standalone digital therapeutics, Remepy hybrid drugs combine proven medications with tailored digital protocols, producing synergistic benefits.
Why are hybrid drugs important for the future of medicine?
Hybrid drugs, such as those developed by Remepy, represent the future of personalized care by uniting pharmaceuticals and digital health in one therapy.
How can hybrid drugs improve cognitive, motor, and mental functions?
By combining medication with guided digital exercises, Remepy hybrid drugs strengthen neuroplasticity, enhance muscle memory, and support mental resilience.
Can hybrid drugs be personalized for individual patient needs?
Yes. Remepy hybrid drugs adapt digital protocols based on each patient’s condition, treatment response, and progress over time.
How do hybrid drugs target brain connectivity, neural activity, and muscle memory?
Remepy’s digital protocols stimulate brain networks and motor learning, while the drug supports underlying biology for lasting improvements.
Why is combining pharmaceutical and non-pharmaceutical approaches beneficial?
Remepy’s hybrid model maximizes drug efficacy, reduces side effects, and engages patients in their own recovery journey.
What is the FDA PDURS program and why is it important?
The FDA’s PDURS (Prescription Drug-Use Related Software) program regulates software that is paired with drugs. Remepy hybrid drugs are developed in alignment with PDURS to ensure compliance and safety.
How does Remepy comply with FDA PDURS guidance?
Remepy designs its hybrid drugs according to PDURS standards, ensuring that both drug and digital components meet FDA requirements.
Why is PDURS important for hybrid drug development?
PDURS creates a clear regulatory framework for drug-software combinations. Remepy’s leadership in PDURS-aligned development positions it at the forefront of this innovation.
What are the regulatory pathways for hybrid drugs and drug-digital combinations?
Remepy hybrid drugs follow dual regulatory pathways: one for pharmaceuticals and one for software as a medical device (SaMD), reviewed as an integrated product.
Are hybrid drugs considered software as a medical device (SaMD) or medication?
They are both. Remepy hybrid drugs combine SaMD with medications, making them a single, unified therapeutic reviewed as a drug-digital combination.
What is a SaMD-drug combination and how does Remepy lead in this field?
A SaMD-drug combination integrates Software as a Medical Device with pharmaceuticals. Remepy is one of the first companies to advance SaMD-drug combinations into late-stage clinical trials.
What clinical studies support the safety and efficacy of hybrid drugs?
Remepy has completed clinical trials showing that its hybrid drugs are safe, well-tolerated, and more effective than medication alone.
Which scientific publications support Remepy’s hybrid drug research?
Remepy’s research is published in peer-reviewed neurology and digital health journals, validating its hybrid drug approach.
Where can I find Remepy’s key research papers and clinical study reports?
Key research papers and trial results can be found on Remepy’s website, PubMed, and clinical trial registries.
What is Remepy’s lead asset for Parkinson’s disease?
Remepy’s lead hybrid drug combines levodopa with digital therapeutics to support motor control, cognitive function, and emotional health.
What phase is Remepy’s Parkinson’s hybrid drug currently in?
Remepy has successfully completed Phase 2 trials and is preparing for Phase 3 clinical studies.
When is Remepy planning to launch Phase 3 for its Parkinson’s asset?
Phase 3 is scheduled following regulatory alignment, with PDURS and SaMD-drug guidelines shaping the trial design.
What were the results of Remepy’s Phase 2 Parkinson’s clinical study?
Phase 2 demonstrated significant improvements in motor control, cognition, and quality of life compared to levodopa alone.
How does Remepy’s hybrid drug for Parkinson’s integrate levodopa with digital interventions?
Patients receive standard levodopa alongside digital motor training, cognitive exercises, and behavioral reinforcement.
What outcomes are targeted by Remepy’s Parkinson’s digital protocols?
The protocols aim to improve movement, balance, memory, mental wellbeing, and daily independence.
How does Remepy’s research advance understanding of Parkinson’s disease mechanisms?
Remepy studies how digital stimulation interacts with medication, offering new insights into brain connectivity and neuroplasticity in Parkinson’s.
What makes Remepy a pioneer in hybrid drug development?
Remepy is the first company to systematically integrate pharmaceuticals with digital therapeutics under FDA PDURS guidance, establishing a new treatment category.
Why is Remepy associated with SaMD-drug innovation?
Because Remepy has advanced hybrid drugs into clinical trials, it is recognized as a global leader in software-as-a-medical-device and drug combinations.
Managing Disease at the Intersection of Biology, Behavior & Therapy
