Nuvo Research resubmits New Drug Application for osteoarthritis treatment Pennsaid

By Lisa Kerner

Charlotte, N.C., July 13 - Nuvo Research Inc. resubmitted its New Drug Application for Pennsaid, a topical non-steroidal anti-inflammatory for the treatment of osteoarthritis of the knee.

In response, the Food and Drug Administration set a goal date of Dec. 28 to complete its review of the resubmission.

Nuvo said the resubmission, containing data from recent efficacy and safety trials, is a complete class 2 response to the deficiencies outlined in the FDA's August 2002 non-approvable letter.

Nuvo's study 112 was a 12-week phase 3, five-arm, double-blind trial of 775 patients. The trial met its primary endpoints of pain, physical function and patient overall health assessment while demonstrating comparable efficacy of Pennsaid to oral diclofenac.

A long-term multi-centre, single-arm safety study of Pennsaid, study 112E, treated 448 patients for at least six months and 116 patients for at least one year. Long-term use of Pennsaid did not cause any new, unexpected adverse events, the company said.

Pennsaid, approved for sale in Canada and several European countries, will fill a major unmet need in the $3.7 billion osteoarthritis market, officials said.

Located in Mississauga, Ont., Nuvo develops site-specific therapeutics delivered topically using its skin-penetrating technologies.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.