The Office of Tissue Advancement Therapies, a branch of the Center for Biologics Evaluation and Research of the FDA, has progressed toward the acceptance of Ampio Pharmaceuticals' Ampion for a viable treatment option for severe osteoarthritis of the knee.
Ampion is part of a small pre-approval study, in which one of six patients with severe osteoarthritis of the knee will be given the treatment, so as to provide a smaller chance of artificial results. The study is to run 12 weeks and will seek to determine if the medication is a legitimate option for all categories of pain, function and patient global assessment.
Ampion has asked for an expedited form of review and approval so that individuals can begin receiving much-needed treatment.
"Ampion has demonstrated a promising effect with a responder rate defined by Osteoarthritis Research Society International, of greater than 50 percent in all of the completed single-injection Ampion trials with no drug-related Serious Adverse Events," Ampio CEO Michael Macaluso said.
The study is to be completed prior to the submission of a Biologicals Licensing Application. Ampio will hold a conference call, when appropriate, to discuss corporate strategy and other Ampion-related issues.