ACNU: Charting The Future of Rx-to-OTC Transitions.
ACNU (Additional Condition For Nonprescription Use) is an innovative FDA guideline that allows qualified prescription medications to transition to over-the-counter (OTC) status. The pathway? Pairing medications with a clinically validated technology-assisted self-selection web app.
Renew Brands.
Breathe new life into established brands. Achieve OTC switches that couldn’t be accomplished with labeling alone.
Expand Reach.
Detailed
Postmarket Data.
Enhance access by offering simplicity and convenience, reaching not just prescription holders, but a wider audience.
Harness detailed data from postmarket reports. Build richer consumer relationships with tailored support.
Transforming Public Health.
Align with the trend of self-care. Support personalized healthcare and bolster public health initiatives.
Our ACNU Journey.
For over seven years, we've been deeply involved in ACNU programs, consistently pushing boundaries and advocating for more accessible medication options. A testament to our commitment and expertise is our recent milestone: successful completion of our program's first Actual Use Study.
Our Dedication to Quality.
Currently, we have five ACNU projects in our development pipeline, reflecting our active role in this transformative space. We take pride in our impressive success rates: a 96% self-selection success and a 97% human factors success. These figures not only showcase our capability but also our dedication to quality and safety in the pharmaceutical landscape.
Leaders in ACNU Technology & Designation.
Introducing CodeScripts
TM
Proprietary Rx-to-OTC Switch technology platform specifically designed for ACNU development, reassessment and data capture.
RWE Approach to ACNU.
Effectively utilizing DS/ML/AI to leverage real-world evidence in forecasting the potential for ACNU designation in Rx drugs.
Regulatory Excellence.
Regulatory team that specializes in ACNU guidance, clinical studies and technical compliance challenges.
Technical Leadership.
Advanced cloud computing, ensuring top-tier cybersecurity and machine learning capabilities.
Launch Partner.
Specializing in market analysis, digital clinical trial recruiting, commercial content strategy and SEM.
Empower Self-Care and Tap into Expanded Marketing with ACNU.