FDA ISSUES APPROVABLE LETTER FOR NUVO'S TOPICAL NSAID

The FDA issued an approvable letter for Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) Pennsaid to treat osteoarthritis of the knee, the company announced.

If approved, Pennsaid (diclofenac) would be the first topical NSAID in the U.S., the company said. With Pennsaid, diclofenac can be delivered directly to the knee through topical application, which will reduce potential side effects associated with oral medications, Nuvo said.

In the letter, the FDA said it would approve Pennsaid if certain conditions were met. While Nuvo did not disclose the conditions, it said it planned to meet with the FDA in early 2007 to discuss the letter.

The company received a not approvable letter for the product in August 2002, and conducted additional studies to meet the agency's safety and efficacy requirements. One Phase III trial involved 775 patients in the U.S. and Canada with osteoarthritis and showed the product's efficacy compared to oral diclofenac.

To address the safety requirements, Nuvo conducted a study treating 793 patients, including 448 patients for at least six months and 116 patients for at least one year. In total, 793 patients were treated. The study found that long-term use of Pennsaid did not cause any new, unexpected adverse events.

Nuvo submitted the amended new drug application to the FDA for review in July. Pennsaid is currently approved in Canada and several European countries.