Ampio Proposes Additional Clinical Trial for Osteoarthritis Treatment

Following meetings with CBER officials, Ampio Pharmaceuticals has proposed an additional pre-approval clinical trial to evaluate its Ampion treatment for osteoarthritis of the knee.

The company proposed a small, 12-week study, randomizing patients 6-to-1 compared to saline.  However, only patients treated with Ampion patients will be evaluated. The company said it expects the label for Ampion to be defined by the study’s outcome. The study will be completed alongside the company’s BLA submission, with requests for expedited review.

The FDA acknowledged an unmet medical need in patients with pain due to severe, high-grade osteoarthritis, which has no currently approved treatments. A previous combined analysis showed statistically significant reductions in pain and improvements in function with the single-injection treatment, said Ampio CEO Michael Macaluso.