Ampio Pharmaceuticals has updated the regulatory status of Ampion™.
The U.S. Food and Drug Administration (FDA) provided guidance that Ampio should complete an additional trial of Kellgren Lawrence Grade 4 (KL 4) osteoarthritis of the knee (OAK) patients with concurrent controls that would be carried out under a Special Protocol Assessment (SPA). Ampio presented the FDA with two different forms of concurrent controls the company was considering in trial design: a saline injection or a sham injection, both previously identified by the FDA as possible controls. FDA correspondence, received on March 5, 2019, allows the Company to use either sham or saline intra-articular injection as a concurrent control in a confirmatory clinical study design.
"Taken as a group, the total KL 4 patient population receiving Ampion within our single injection clinical trials provided statistically significant superior results compared to those patients receiving the saline injection control,” Michael Macaluso, Ampio's CEO said. “Therefore, we feel confident with the choice of either control option. The company will quickly determine which control to include in our trial design and then update and resubmit our SPA. We will be ready to begin the confirmatory clinical trial as soon as the SPA is awarded."
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