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Imprimis Pharmaceuticals, Inc. Receives Institutional Review Board (IRB) Approval for its Phase III Clinical Trial Protocol; Phase III Clinical Trial to Begin in 3Q 2013
Date:7/22/2013

SAN DIEGO, July 22, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), which is focused on the commercialization of compounded drug formulations utilizing the FDA 505(b)(2) development pathway, today announced it has received IRB approval for its Phase III clinical trial protocol of its lead product candidate, Impracor™. Imprimis has engaged Agility Clinical, Inc., a Carlsbad, CA-based consulting and contract research organization (CRO), to conduct the study at 20 - 30 US sites. The IRB-approved Phase III trial is a randomized, multicenter, double-blind, parallel-group study to assess the efficacy and safety of Impracor (ketoprofen 10% cream) compared with placebo in the treatment of acute pain (flare) associated with osteoarthritis (OA) of the knee.

As previously announced, Imprimis designed the Phase III study with the assistance of key opinion leaders, and also relied upon feedback from the U.S. Food and Drug Administration (FDA) following a Type C meeting between Imprimis and FDA officials in April 2013.

"This is an important and critical step forward for Imprimis as we prepare to start enrollment of our Phase III clinical trial in the third quarter of this year," said Imprimis CEO Mark L. Baum. "The IRB approval of this protocol in many ways represents the culmination of a year of hard work, and marks the initiation of our Impracor Phase III study. With Agility as our clinical operations team, we have an experienced partner that will help us bring forward a new alternative therapy in the space of anti-inflammatory, pain-relieving drugs, to improve patient h
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SOURCE Imprimis Pharmaceuticals, Inc.
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