Fortrea and Emery Pharma have announced a strategic collaboration to conduct FDA-compliant drug-drug interaction (DDI) studies utilizing rifampin. This partnership aims to address the regulatory challenges posed by nitrosamine impurities, specifically 1-methyl-4-nitrosopiperazine (MNP), found in rifampin formulations. These impurities had previously led to the suspension of rifampin's use in healthy volunteer DDI studies due to safety concerns.

Rifampin is a potent inducer of cytochrome P450 3A (CYP3A) enzymes and has been a cornerstone in evaluating the metabolic interactions of new drug candidates. However, the detection of MNP above acceptable intake limits necessitated the exploration of alternative inducers, such as phenytoin and carbamazepine. These alternatives, while viable, do not fully replicate rifampin's induction profile, potentially impacting the assessment of drug metabolism and safety.

The collaboration leverages Fortrea's extensive experience in clinical trial execution and regulatory strategy, combined with Emery Pharma's expertise in bioanalytical chemistry and method development. Together, they aim to develop and validate analytical methods that ensure rifampin formulations meet FDA's stringent impurity thresholds, thereby reinstating its use in DDI studies.

This initiative not only seeks to restore rifampin's role in clinical pharmacology but also underscores the importance of rigorous analytical standards in safeguarding public health. By addressing the impurity challenges, Fortrea and Emery Pharma are contributing to more accurate and reliable DDI ass…