How Do You Transition an Rx Drug to Over-the-Counter Use?

THE CHALLENGE

OTC drugs can empower patients to manage conditions and symptoms, with the notable benefit of widespread — and often affordable — access. Transitioning a prescription drug to OTC requires extensive real-world usage data and thorough clinical safety documentation. Collecting data from various sources can be difficult for drugmakers who don't have access to all clinical research.

EXPONENT'S MULTIDISCIPLINARY SOLUTION

Exponent pharmaceutical and medical experts reviewed studies and documentation about adverse events with the drug class. Medical experts evaluated peer-reviewed literature, and data scientists compiled information from postmarketing databases to quantify risks associated with transitioning the drug from prescription to OTC.

EXPONENT'S IMPACT

Patients must be able to use an Rx drug safely in a non-prescription setting for it to be considered an appropriate OTC candidate. To help establish this use case for our pharmaceutical client, Exponent assembled the safety evidence into an integrated summary of safety (ISS) supporting their Rx-to-OTC switch. With Exponent's assistance, our client successfully navigated the process of preparing their regulatory submission, ultimately progressing toward providing consumers with greater choice and agency in their personal health decisions. Exponent's approach reflects an effective lifecycle management tool for life sciences companies in transitioning mature candidate drug products with extensive and long-term safety data to OTC for broader availability.