Markets

Ampio (AMPE) Starts Final Phase III Study on Knee Pain Drug

Ampio Pharmaceuticals, Inc.AMPE announced that it has initiated the second phase III study on Ampion for the treatment of pain and inflammation due to osteoarthritis of the knee. The company reached a Special Protocol Assessment (SPA) agreement with the FDA related to the study. Shares of Ampio gained almost 6% following the announcement.

We note that a SPA defines the study protocol including the endpoints required for approval of a candidate and significantly lowers the risks involved in the process and its commercialization.

This study is the final of two pivotal studies on Ampion, required by the FDA, to allow the company to submit a biologics license application for the candidate for the treatment of pain and inflammation due to knee osteoarthritis. The company said that the second phase III study on Ampion will be clinically identical to the first phase III Spring study on the candidate. Spring study met its primary endpoint and results were announced in 2013.

We note that Ampion is one of the late-stage candidates in the company's pipeline. Apart from Ampion, Ampio is working on developing Zertane, for the treatment of premature ejaculation. The company plans to initiate a phase III study on the candidate later this year. Being a development-stage company, Ampio largely depends on the successful development of its candidates for future growth.

Meanwhile, other companies are also working on developing new therapies for the treatment of osteoarthritis of the knee. Flexion Therapeutics FLXN is studying FX006 as an intra-articular therapy for moderate-to-severe pain due to knee osteoarthritis. Earlier this month, the candidate received fast track designation from the FDA for this indication. Additionally, Cytori Therapeutics CYTX is evaluating ECCO-50 in a phase IIb study for the treatment of patients suffering from knee osteoarthritis.

Investors looking for well-ranked stocks may consider Corcept Therapeutics Inc. CORT , carrying a Zacks Rank #1 (Strong Buy). Flexion holds a Zacks Rank #2 (Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

CYTORI THERAPEU (CYTX): Free Stock Analysis Report

CORCEPT THERAPT (CORT): Free Stock Analysis Report

FLEXION THERAPT (FLXN): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story

CORTPSTV

Other Topics

Stocks

Latest Markets Videos

Zacks

Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at www.zacks.com.

Learn More