Imprimis Pharmaceuticals, Inc., a company focused on the commercialisation of compounded drug formulations utilizing the FDA 505(b)(2) development pathway, has received Institutional Review Board (IRB) approval for its phase III clinical trial protocol of its lead product candidate, Impracor.
Imprimis has engaged California-based, Agility Clinical, Inc., a consulting and contract research organisation (CRO), to conduct the study at 20 - 30 US sites. The IRB-approved phase III trial is a randomized, multi-centre, 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 US 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 health and quality of life. We are delighted to be working with Dr Neil Singla of Lotus Clinical Research, who has an excellent track record in conducting successful trials in the pain sector."
"We are excited that the Imprimis phase III protocol was approved by an independent central ethics committee, Schulman Associates Institutional Review Board, Inc.," said Imprimis chief medical officer Dr Joachim Schupp. "This is an important milestone to commence our phase III study in the third quarter of this year. The primary role of an IRB is to safeguard the rights, safety and welfare of participants in research. Agility Clinical and Lotus Clinical Research were instrumental in the final protocol and informed consent preparation."
"Helping innovative companies bring new treatments to patients is an important part of Agility's mission," said Ellen Morgan, CEO of Agility Clinical. "We are excited to be working with Imprimis and Lotus Clinical Research on this study. If approved, Impracor will provide patients suffering from osteoarthritis of the knee with an alternative to systemic NSAIDs for the management of their pain."
"We appreciate the opportunity to work with Imprimis Pharmaceuticals, Inc. and Agility Clinical on this important clinical trial," said Dr Neil Singla, Owner of Lotus Clinical Research. "All parties have worked diligently over the past several months to design a robust protocol that will answer many critical regulatory and therapeutic questions concerning Impracor."
Imprimis has commenced the investigational site selection for training, qualification and study initiation.
Imprimis Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the commercial development of compounded drug formulations.