Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway

An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. The client approached Camargo with the concept that Product X could be superior to the approved drug in several areas:

• Reduction of inter-individual variability and more consistent drug effect, including individuals who are considered poor metabolizers, compared to the approved drug.
• A faster onset of action than the approved drug.
• Minimization of drug-drug interactions when compared to the approved drug.
• Improved safety profile, especially when compared to newer drugs in the same class.

Assessing these areas required filing an Investigational New Drug (IND) application with the FDA to administer X to humans in a clinical trial. Camargo and XenoTech jointly developed the series of studies designed to provide the necessary data for a successful pre-IND meeting.

In vitro hepatocyte and intestinal microsomal metabolism studies helped establish the case for toxicology testing in a single animal — an accomplishment that in itself saved the client substantial development costs and time. Among the species tested, monkey hepatocyte profiles were the closest match to human hepatocyte profiles for both the approved drug and Product X incubations. The monkey intestinal microsome profile also most closely matched the human microsome profile. These data were further confirmed in a radiolabeled in vivo ADME study in cynomolgus monkeys.