Nuvo Research Inc. Receives Approvable Letter From U.S. FDA For Pennsaid
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 commercialization of Pennsaid in the U.S.," 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 Drug Application (NDA) for Pennsaid was re-submitted to the FDA and accepted for review in July 2006. To meet the FDA's clinical efficacy and safety requirements as stated in an August 2002 non-approvable (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 U.S. 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.
To address the long-term safety requirements as stated in the August 2002 NA letter, Nuvo conducted study 112E, 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.
About Pennsaid
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. According to published clinical trials, Pennsaid is as effective as the maximum daily dose of comparable oral medication at relieving pain and stiffness associated with osteoarthritis of the knee, as well as improving overall well-being.
About Nuvo Research Inc.
Nuvo is focused on developing innovative site-specific therapeutics that are delivered topically using the Company's skin-penetrating technologies. Nuvo's lead product is Pennsaid(R), a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of transdermal products targeting a variety of indications.
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with its research and development facility in San Diego, California and manufacturing facilities in Varennes, Quebec and Wanzleben, Germany. For more information, please visit http://www.nuvoresearch.com.
This release may contain forward-looking statements, subject to risks and uncertainties beyond management's control. Actual results could differ materially from those expressed here. Risk factors are discussed in the Company's annual information form filed with the securities commissions in each of the provinces of Canada. The Company undertakes no obligation to revise forward-looking statements in light of future events.
SOURCE Nuvo Research Inc.