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news.Alabama-based prescription products distributor ProEthic Pharmaceuticals has submitted an investigational new drug application to the FDA, to develop a non-steroidal anti-inflammatory drug transdermal delivery patch.
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Following a 30-day waiting period after the submission of the investigational new drug (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 in the first quarter of 2005 with late-stage studies beginning later this year.
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 non-steroidal anti-inflammatory drug (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.”