What is the Probuphine REMS Program?

Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure the benefits of a drug outweigh its risks. ReacX Pharmaceuticals, Inc.1 has worked with the FDA to develop the Probuphine REMS Program to mitigate the risk of complications of migration, protrusion, expulsion, and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse.

REMS Program Overview

Scroll to Top