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Medinox Announces Clinical Results of Naproxen Prodrug
Date:5/26/2009

SAN DIEGO, May 26 /PRNewswire/ -- Medinox, Inc. (Carlsbad, CA) and its development partner, Logical Therapeutics, Inc. (Waltham, MA) announced the results of a double-blind, randomized, active comparator study of LT-NS001 (formerly MX-1094) vs naproxen, in subjects 45 to 70 years of age. LT-NS001 is a novel, patented NCE prodrug of the popular non-steroidal anti-inflammatory drug (NSAID) naproxen, which is being developed to significantly reduce the GI safety risks, including the formation of ulcers, associated with naproxen. Naproxen is widely regarded as the NSAID with the most favorable cardiovascular safety profile among all of the drugs in this class.

In this study, subjects underwent upper endoscopies at baseline and on day seven. Subjects receiving LT-NS001 experienced statistically significantly fewer endoscopically confirmed gastric ulcers compared to subjects receiving naproxen.

LT-NS001 is pharmacologically inactive as an NSAID in the GI tract, but once absorbed into the blood stream, it is converted rapidly and quantitatively to naproxen. It is being developed to provide therapeutic levels of naproxen while avoiding high local concentrations of naproxen in the GI tract, thereby reducing the local GI toxicity associated with conventional naproxen.

LT-NS001 has been studied in various randomized controlled single-dose and multiple-dose clinical studies. In all cases, there were no serious adverse events and LT-NS001 was well tolerated. Moreover, when the subjects were dosed twice daily with LT-NS001, plasma concentrations of naproxen were within the therapeutic range.

NSAIDs are the most common medications taken worldwide for the treatment of pain, inflammation, fever and arthritics, including both rheumatoid arthritis (RA) and osteoarthritis (OA). The use of NSAIDs is associated with serious side effects, the most frequent being an increased rate of gastric and duodenal ulcer
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SOURCE Medinox, Inc.
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