The resubmission of the new drug application (NDA) addresses deficiencies in the original application outlined by the FDA in a non-approvable letter in August 2002. The FDA has indicated that its goal date to complete its review of the resubmission is December 28, 2006. 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 US osteoarthritis market.”
To meet the FDA’s clinical efficacy and safety requirements as stated in the non-approvable letter, Nuvo conducted a 12-week phase III trial of 775 patients. This trial enrolled patients in the US 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, Nuvo conducted a long-term multi-centre, single-arm safety study of Pennsaid applied by patients with symptoms of osteoarthritis 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.