AMPE - Ampio stock slumps 33% as FDA disagrees with changes to trial unblinding data for pain drug Ampion

Ampio Pharmaceuticals' (NYSE:AMPE) said the U.S. Food and Drug Administration (FDA) did not agree with proposed changes made to a phase 3 trial for pain drug Ampion and that the company should have sought the regulator's nod before unblinding the data. The company was evaluating Ampion in a phase 3 trial, dubbed AP-013, to treat pain due to osteoarthritis of the knee (OAK). The company had submitted a Type C meeting request to the FDA to get clarity on the acceptability of the proposed modified intent-to-treat (mITT) population as the primary analysis population for evaluating efficacy in the AP-013 trial, and the acceptability of AP-013 as a second trial to support a biologics license application (BLA) for Ampion. In March, however, the company released data from the study. Ampio's President and Chief Operating Officer Holli Cherevka said in a March 2 release that the FDA had recommended to  conduct a sensitivity analysis to determine if there was an

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Ampio stock slumps 33% as FDA disagrees with changes to trial, unblinding data for pain drug Ampion