Pennsaid is currently approved for sale in Canada and several European countries. The phase III trial, named Study 112, was designed with the advice and recommendations provided by the FDA to address specific deficiencies identified in a non-approvable letter received by Nuvo in August 2002.
The trial results confirm the efficacy of Pennsaid that has been demonstrated in prior phase III trials.
“We are pleased with these robust results and believe they will satisfy the FDA’s key efficacy concerns,” said Dr Henrich Guntermann, Nuvo’s president and CEO. “We are now working towards our next milestone – the submission of an amended new drug application to the FDA. If approved, Pennsaid will fill a major unmet need in the $6.5 billion osteoarthritis market.”
Study 112 enrolled 775 patients in the US and Canada with symptoms of primary osteoarthritis of the knee.