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."
"We are happy with the successful outcome of this FDA recommended pharmacokinetic study comparing blood levels of ketoprofen under different 'real world' conditions," said Dr. Joachim Schupp, Imprimis Chief Medical Officer. "The results are consistent with previous pharmacokinetic findings with Impracor and provide guidance for safe dosing in our upcoming efficacy trials," Dr. Schupp added.
The study was conducted by Novum Pharmaceutical Research Services, based in Pittsburgh, PA, at the in-house clinical research facility in Las Vegas, NV. PPD Laboratories in Middleton, WI performed the analysis of the active drug in the blood samples.
About Imprimis Pharmaceuticals, Inc.
Imprimis Pharmaceuticals is a specialty pharmaceutical company focused on the commercial development of compounded drug formulations. Through an exclusive strategic relationship with the largest compounding pharmacy organization in North America, Imprimis expects to use its proprietary Accudel drug delivery technology, coupled with licensed technologies, and proprietary formulations and market data, to identify pharmaceutical development opportunities where there is a significant unmet need for a new drug product. Imprimis is also internally developing non-invasive, topically delivered products. Our innovative patented Accudel cream formulation technology is designed to enable highly targeted site-specific treatment. Impracor, our lead Phase 3 pain product candidate, utilizes the Accudel platform technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug, through the skin directly into the underlying tissues where the drug exerts its localized anti-inflammatory and analgesic effects. We intend to leverage the Accudel platform technology to expand and create a portfolio of topical products for a variety of indications. For more information, visit http://imprimispharma.com/.
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products and to enter into strategic alliances and transactions, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in Imprimis' filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Contact: Mark L. Baum
Imprimis Pharmaceuticals, Inc.
SOURCE Imprimis Pharmaceuticals, Inc.