Osteoarthritis Drug Development: ‘Clinically Meaningful Endpoints’ Remain Elusive

US FDA is ‘willing to look at anything’ but sponsors need to demonstrate an effect on pain as drug development challenges remain. Accompanying chart describes 32 drugs in Phase II and Phase III clinical trials and one with a pending biologics license application.

The landscape looks bleak for development of osteoarthritis drugs that can modify the underlying disease and slow its progression. But the US Food and Drug Administration, drug sponsors and academics are striving to overcome the area's unique challenges, which include identifying meaningful clinical endpoints.

Stakeholders delved into the topic at an all-day workshop convened by the FDA and the Arthritis Foundation in June. Osteoarthritis...