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Pennsaid

Generic name: diclofenac sodium
Treatment for: Osteoarthritis

Update: Pennsaid Now FDA Approved - November 4, 2009

Nuvo’s Pennsaid NDA Resubmission Accepted for Review by U.S. FDA

MISSISSAUGA, Ontario, July 13, 2006 - Nuvo Research Inc. today announced that it has resubmitted its New Drug Application (NDA) for Pennsaid, a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis of the knee to the U.S. Food and Drug Administration (FDA). The FDA has confirmed that it has received Nuvo's resubmission for review and has indicated that its goal date to complete its review of the resubmission is December 28, 2006. The resubmission is a complete Class 2 response to the deficiencies outlined in an August 2002 Non-Approvable (NA) letter issued by the FDA with respect to Pennsaid. Pennsaid is currently approved for sale in Canada and several European countries.

"This resubmission is the result of significant efforts by our employees, management and our FDA advisory board," said Dr. Henrich Guntermann, Nuvo's President and CEO. "This NDA resubmission contains data collected from recent efficacy and safety trials that were designed to answer the FDA's key concerns. If approved, Pennsaid will fill a major unmet need in the $3.7 billion U.S. osteoarthritis market."

To meet the FDA's clinical efficacy and safety requirements as stated in the NA letter, Nuvo conducted study 112, a 12-week Phase III, 5-arm, double-blind trial of 775 patients. This trial enrolled patients in the U.S. and Canada with symptoms of primary osteoarthritis of the knee. The trial met all of its primary endpoints, being pain, physical function and patient overall health assessment. The trial also demonstrated comparable efficacy of Pennsaid to oral diclofenac.

To address the long-term safety requirements as stated in the NA letter, Nuvo conducted study 112E, a long-term multi-centre, single-arm safety study of Pennsaid applied by patients with symptoms of osteoarthritis (OA) of the knee. In total, 793 patients were treated, including 448 patients for at least six months and 116 patients for at least one year. The key observation was that long-term use did not cause any new, unexpected adverse events.

Source: Nuvo Research Inc.

Posted: July 2006

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