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ProEthic Files IND for Transdermal NSAID Patch

Pharma Company Submitting FDA Application to Begin Studies in Patients with Sport Injuries Using a Through-the-Skin Delivery System

Montgomery, Alabama, --(BUSINESS WIRE)-- January 11, 2005 - ProEthic Pharmaceuticals Inc., a Montgomery, Ala.-based marketer and distributor of an exclusive line of prescription products, has submitted an Investigational New Drug (IND) Application to the Food and Drug Administration to develop a non-steroidal anti-inflammatory drug (NSAID) transdermal delivery patch.

Following a 30-day waiting period after the submission of the IND application, ProEthic will begin clinical trials on patients with sports-related, soft-tissue injuries, such as tendonitis and joint sprains. Early phase trials are anticipated to start this quarter with late-stage studies beginning later in 2005.

The patch, which has been studied extensively in Europe and is expected to receive formal approval in France this year, delivers the active drug directly to the area of inflammation, unlike existing NSAID oral delivery systems, which send high levels of medication throughout the body.

“The observed systemic blood levels of the NSAID delivered by the transdermal delivery system are markedly less than those reached by the oral dosage form of the NSAID, which should lead to fewer gastrointestinal and other adverse side effects,” said William Maichle, director of product development for ProEthic. “Given the increased focus by regulators, clinicians and the general public on the safety of the Cox-2 inhibitors and traditional oral NSAIDs, ProEthic believes that this product has a promising future to treat various inflammatory conditions in a safer and more effective manner than NSAID treatments currently available.”