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Nuvo Gets Positive Results for Osteoarthritis Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Nuvo Research, Inc. achieved positive results from its Phase III trial (Study 112) of Pennsaid, a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis. Pennsaid is currently approved for sale in Canada and several European countries. The trial was designed with the advice and recommendations provided by the FDA to address specific deficiencies identified in the FDA non-approvable letter received by Nuvo in August 2002. The trial results confirm the efficacy of Pennsaid that has been demonstrated in previous Phase III trials.

Study 112 enrolled 775 patients in the U.S. and Canada with symptoms of primary osteoarthritis of the knee. The double-blind, 12-week trial showed that Pennsaid was superior to placebo with statistically significant improvement in all three primary clinical endpoints required by the FDA: pain relief, improvement in physical function and improved patient overall health assessment.

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