NUVO RESUBMITS NDA FOR NSAID

Nuvo Research has announced that it has resubmitted its new drug application (NDA) for Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of osteoarthritis of the knee, to the FDA. The resubmission is a response to an August 2002 "not approvable" letter issued by the FDA for to Pennsaid. The drug is currently approved for sale in Canada and several European countries.

To meet the requirements of the letter, Nuvo conducted a 12-week, Phase III, five-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.

To address the long-term safety requirements outlined in the letter, Nuvo conducted a long-term multicenter, single-arm safety study. 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.