Nuvo Research Inc. has received an approvable letter from the US Food and Drug Administration (FDA) for Pennsaid (1.5% w/w diclofenac sodium solution), a topical non-steroidal anti-inflammatory (NSAID) developed by Nuvo for use as a treatment of osteoarthritis (OA) of the knee.
Pennsaid is based on Nuvo's skin-penetrating technology that allows diclofenac to be delivered directly to the knee via topical application to the surface of the skin thus minimizing systemic side effects often associated with oral therapies.
In its letter, the FDA indicated that Pennsaid is approvable subject to Nuvo satisfying certain conditions. The company plans to meet with the FDA early in 2007 to discuss the letter. "This approvable letter is a great achievement for our Company and a step forward to the commercialisation of Pennsaid in the US," said Dr Henrich Guntermann, Nuvo's president and CEO. "We plan to work closely with the FDA to resolve these outstanding matters required to obtain final approval and expect to provide further information following our meeting with the FDA."
The Arthritis Foundation estimates that more than 21 million Americans suffer from osteoarthritis. Pennsaid would be the first topical NSAID product approved in the United States where the osteoarthritis pain relief market is estimated at $4 billion US. Nuvo's amended new efficacy and safety requirements as stated in an August 2002 non-approvable Drug Application (NDA) for Pennsaid was re-submitted to the FDA and accepted for review in July 2006. To meet the FDA's clinical (NA) letter, Nuvo conducted study 112, a 12-week phase III, 5-arm, double-blind 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. In total, more than 2,500 patients have been exposed to Pennsaid in clinical studies.
Pennsaid is a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis and is currently approved for sale in Canada and several European countries. Pennsaid allows the diclofenac solution to be delivered to a specific site via the surface of the skin and thus avoids complications associated with systemic
delivery.