Investigating the FDA's Appraisal of Preclinical Studies in New Drug Applications for Pain Indications and its Implications for Pepducin P4pal-10

Abstract

Musculoskeletal diseases are responsible for a large proportion of disabling conditions, with chronic pain being the primary concern for patients. Current drug options are limited and often associated with adverse side effects. In the area of arthritis treatment, the proteinase-activated receptor-4 (PAR4) antagonist pepducin P4pal-10 has emerged as a promising target. It has been shown previously that P4pal-10 can reduce joint pain and inflammation in rodent models of arthritis. The preparatory goal of this project was the confirm the analgesic capacity of P4pal-10 in the FCA model of inflammatory joint disease. The FDA generally require pharmaceutical companies to submit animal studies as part of their New Drug Application. By understanding FDA decision-making at the pre-clinical stage, salient aspects can be identified which may then be applied to inform the developmental trajectory of P4pal-10 and its likelihood as a candidate compound for the treatment of pain and inflammation in arthritis.