Imprimis Pharma Gets IRB Approval For Phase III Trial Protocol For Impracor

(RTTNews) - Imprimis Pharmaceuticals Inc. (IMMY) announced it has received Institutional Review Board or 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 or 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 or OA of the knee.

The company said it prepares to start enrollment of its Phase III clinical trial in the third quarter of this year.

The company 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.

The company noted that it has commenced the investigational site selection for training, qualification and study initiation.