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 The leading web portal for pharmacy resources, news, education and careers September 22, 2017
Pharmacy Choice - Pharmaceutical News - Ampio Receives Guidance from the FDA and Proposes a Path for Approval for Single-Injection Ampion for the Treatment of Pain Due to Severe... - September 22, 2017

Pharmacy News Article

 3/18/17 - Ampio Receives Guidance from the FDA and Proposes a Path for Approval for Single-Injection Ampion for the Treatment of Pain Due to Severe...

Ampio Receives Guidance from the FDA and Proposes a Path for Approval for Single-Injection Ampion for the Treatment of Pain Due to Severe Osteoarthritis of the Knee

By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced that the Office of Tissue and Advanced Therapies (OTAT), a branch of the Center for Biologics Evaluation and Research (CBER) of the FDA, has recently provided additional guidance for the path to approval of Ampion? as a treatment for pain due to severe Osteoarthritis of the knee (OAK) (see also Pharmaceutical Companies).

The FDA acknowledged an unmet medical need in patients with pain due to severe OAK, graded as Kellgren-Lawrence Grade 4 (KL 4), where there are currently no FDA approved treatments for this population.

"Ampion? has demonstrated a promising effect with a responder rate defined by Osteoarthritis Research Society International (OARSI), of greater than 50% in all of the completed single-injection Ampion?-trials with no drug-related Serious Adverse Events" stated Michael Macaluso, CEO of Ampio. "Additionally, combined analysis of this population in our prior single-injection studies show that Ampion? was statistically significant in the mean reduction of pain, function and patient global assessment. To our knowledge, Ampion? has the largest experience in safety and efficacy data in the severe OAK patient population."

Based on the FDA guidance, Ampio has proposed a small pre-approval study, randomized 6 to 1 (Ampion?/Saline) on patients with severe OAK, defined radiologically as KL 4 patients. The proposed 6-1 randomization is intended to preserve blinding and prevent bias. However, only Ampion? treated patients will be evaluated. The study will be completed concurrently with preparation for the Biologicals Licensing Application (BLA) submission. The proposed design of this 12-week study evaluates the responder rate of Ampion? treated patients as defined by OARSI, which includes pain, function, and patient global assessment. The label of Ampion? will be defined by this study outcome, as we seek a label that includes pain, function, and patient global assessment. Ampio has requested expedited review/approval for this serious medical condition with an unmet medical need.

As soon as practical Ampio will announce a time for a conference call to address corporate strategy, and the expansion of additional indications for Ampion?.

Keywords for this news article include: Ampio Pharmaceuticals Inc., Pharmaceutical Companies, FDA Actions, Osteoarthritis, Joint Diseases and Conditions, Rheumatic Diseases and Conditions, Musculoskeletal Diseases and Conditions.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC



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