Imprimis Pharmaceuticals has received approval from the Institutional Review Board (IRB) to initiate Phase III clinical trial protocol of its new topical non-steroidal anti-inflammatory drug (NSAID) candidate, Impracor.
Impracor is based on the combination of patented Accudel cream and 10% of the active pharmaceutical ingredient ketoprofen.
The IRB-approved Phase III randomized, multicenter, double-blind, parallel-group study will assess the efficacy and safety of Impracor against placebo in the treatment of acute pain (flare) associated with osteoarthritis (OA) of the knee.
Imprimis CEO Mark Baum said, "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."
The company has engaged Agility Clinical, which is a consulting and contract research organization (CRO), to manage the initiation and execution of the trial, which will be conducted at 20-30 sites in the US.
Agility Clinical CEO Ellen Morgan added, "If approved, Impracor will provide patients suffering from osteoarthritis of the knee with an alternative to systemic NSAIDs for the management of their pain."
