Imprimis to Begin New Study of Its Topical Analgesic Drug Pharmacokinetic Study to Compare Blood Levels of Ketoprofen Under Different "Real World" Conditions
SOLANA BEACH, Calif., Sept. 19, 2012 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (IMMY:OTCQB) today announced the initiation of a clinical study of Impracor™, a topical cream that delivers a dose of the pain-relieving, anti-inflammatory drug ketoprofen. The study will measure the amount of ketoprofen found in the bloodstream following topical application of two different doses of the anti-inflammatory cream under different "real world' conditions, including normal activities, heat exposure to the application site and exercising on a treadmill. The amount of the drug in the bloodstream after taking an oral dose of ketoprofen will also be studied in healthy volunteers.
Impracor is designed to be applied to the site of muscle or joint pain, delivering a clinical dose of the active drug ketoprofen in its proprietary topical-delivery platform Accudel™ to the affected area. Current prescription ketoprofen (a non-steroidal anti-inflammatory drug, NSAID) is only available in an oral formulation in the US and is used to relieve pain and inflammation in various musculoskeletal conditions. Topical delivery of NSAIDs is recognized as safe pain medication that significantly reduces side effects, especially less stomach irritation, cardiac or liver problems compared with NSAIDs taken by mouth.
Imprimis believes its patented topical-delivery platform Accudel™ can also serve as a delivery vehicle for other medications. Going forward, the company plans to employ a strategy of repurposing or reformatting existing FDA-approved generic drugs to be used in combination with Imprimis's delivery platform to create entirely new medications to address unmet therapeutic applications.
"We are pleased to achieve an important milestone for our company, which we expect to be the first of many such advances as we pursue FDA approval of our lead pain and anti-inflammatory product, Impracor™ and consider other potential product candidates utilizing our unique Accudel™ topical drug-delivery platform as we implement our business model," said Mark L. Baum, CEO of Imprimis.
Imprimis has selected Novum Pharmaceutical Research Services, based in Pittsburgh, PA, to conduct the study in 40 healthy human subjects, and PPD Laboratories to perform the analysis of the active drug in the blood samples.
"We believe this study marks a major step forward to understanding the influence of different conditions on the absorption of topical ketoprofen," said Dr. Joachim Schupp, Imprimis's Chief Medical Officer. "Members of our Science and Regulatory Advisory Board did an outstanding job in assisting us with the trial protocol, culminating in the FDA clearing the protocol for initiation. The Phase I clinics at Novum Pharmaceutical Research Services have a strong reputation for conducting pharmacokinetic and bioavailability studies," Dr. Schupp added.
"We expect the study will build on previous research that suggests the topical delivery of ketoprofen results in minimal levels of the drug in the bloodstream compared with what is known for an oral dose of the medication," said Dr.Schupp.
The study is expected to be completed during the fourth quarter of 2012.
"We are gratified to have been selected to work with Imprimis Pharmaceuticals to conduct this study for the evaluation of its lead pain product Impracor, and we are committed to the successful execution of this study, which is intended to provide data to meet FDA requirements," said Chris Hendy, Ph.D., President of Novum.
About Imprimis Pharmaceuticals, Inc.
Imprimis Pharmaceuticals is a specialty pharmaceutical company 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 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.
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's reports filed 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.