Biopharmaceutical company Ampio Pharmaceuticals, Inc (NYSE MKT:AMPE) reported on Friday the receipt of US FDA approval of the special protocol assessment (SPA) of a clinical protocol titled 'A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee'.

The FDA has reportedly completed its review and based on the information submitted, the agency has agreed that the design and planned analysis of the company's study adequately address the objectives necessary to support a regulatory submission.However, the final determinations for marketing application approval are made after a complete review of the marking application and are based on the entire data in the application, added the US FDA

According to the company's CEO Michael Macaluso, it has identified and engaged 15 clinical sites for the AP-013 trial and patient identification is underway. This pivotal trial will enrol 1,000 patients, with an interim look, to allow sample size adjustments, if required. This trial will assess co-primary endpoints of pain and function.

Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments and bone.