NUVO UPDATES STATUS OF ITS APPLICATION FOR PENNSAID

Nuvo Research has announced an update on its discussions with the FDA regarding the approvable letter the agency issued in December 2006 for Pennsaid, a non-steroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis.

In a recent meeting, the company and the FDA discussed additional requirements for approval outlined in the approvable letter. The matters raised in the letter do not relate to clinical efficacy or safety of Pennsaid as demonstrated in Nuvo's Phase III trials, and the FDA has not requested that Nuvo conduct any additional Phase III clinical trials. But in order to resolve certain matters, the company may be required to generate additional data.

None of the issues brought up in the approvable letter were raised by the FDA in the not approvable letter sent in August 2002, to which Nuvo responded when it resubmitted its application for Pennsaid in June 2006.

"We are obviously disappointed that approval of Pennsaid may be delayed," Henrich Guntermann, Nuvo's president and CEO, said. "We will continue to work with our advisers and the FDA to determine the appropriate path forward to secure the approval of Pennsaid in the U.S."

Pennsaid is currently approved for the treatment of osteoarthritis in Canada and several European countries. The product allows diclofenac to be delivered to a specific site via the surface of the skin and thus limits complications associated with systemic delivery. There is currently no topical NSAID product approved in the U.S., according to Nuvo.