SOLANA BEACH, Calif.,
Feb. 19, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (IMMY:NASDAQ) today announced the completion of a clinical study of Impracor™, a topical analgesic cream that delivers a therapeutic dose of the pain-relieving, anti-inflammatory drug ketoprofen. The study measured the amount of ketoprofen found in the bloodstream following topical application of two different doses of the anti-inflammatory cream under different conditions, including normal activities, heat exposure to the application site and exercising on a treadmill. In addition, the amount of the drug in the bloodstream after taking an oral dose of ketoprofen was studied in 40 healthy volunteers assigned to one of two cohorts (2g or 4g applications). Subjects were dosed according to a four-sequence, four-treatment randomization schedule in which they received topical Impracor applications under each of the three conditions and an oral ketoprofen dose in weekly intervals.
Overall the pharmacokinetic parameters were very consistent between the two different dose cohorts. The application of an occlusive knee bandage with either heat or exercise following topical administration showed faster initial but lower overall plasma exposure of ketoprofen relative to non-occluded topical administration with no heat or exercise. The extent of bioavailability over 48 hours as measured by the Area under the concentration curve from time zero to the time of last measurable concentration (AUC0-t) was 2% or less in Cohort 1 (2 g single dose applied to one knee) and 4% or less in Cohort 2 (2 g single dose applied to each knee) for the topical treatments relative to the oral treatment.
All treatments were well tolerated. The full data presentation will be reserved for upcoming clinical conferences.
Mark L. Baum, Imprimis Chief Executive Officer stated, "I am very pleased with the results of this important study which the FDA has mandated as a part of the clinical development of our Impracor topical NSAID program. This study provides us with greater confidence in the performance of Impracor as we ready our team for our Phase 3 human clinical trials which are being planned to start in a matter of months."