Line Extension Trial for an Analgesic Program

Project Summary: A pharmaceutical company was about to undertake a Phase IV program for a powerful analgesic. Rosa developed a model to explain complex observations that accompanied a reduced drug effect over time and support the product’s label extension.

Methods: Rosa developed a PK/PD model to deal with observed drug accommodation and complex placebo effects in the context of a cross-over study design.

Results:

• Explained significant differences in study results between active and placebo arms.
• Supported extension of the product’s label into a new indication based on data from an approved indication and model simulation results.