Ampio Regulatory And Clinical Update

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today that it received FDA approval of the Company’s 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 response noted “We have completed our review, and based on the information submitted, agree that the design and planned analysis of your study adequately address the objectives necessary to support a regulatory submission.”

The FDA continued, “However, 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.”

According to Michael Macaluso, Ampio CEO, “The Company has identified and engaged 15 clinical sites for the trial (AP-013) and patient identification is underway. This pivotal trial seeks to enroll approximately 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. More details of the study will be made available on clinicaltrials.gov.”- PR Newswire

Share this:

Related Post

Stay Updated on Medical Equipment and Devices industry.
Receive our Daily Newsletter.