MARKHAM, ON, Jan. 16 /PRNewswire-FirstCall/ - Nuvo Research Inc. today announced detailed positive results of its Phase III Clinical Trial ("Study 112") of Pennsaid(R), a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis. Pennsaid(R) is currently approved for sale in Canada and several European countries. The trial was designed with the advice and recommendations provided by the U.S. Food and Drug Administration (FDA) to address specific deficiencies identified in the FDA non-approvable letter received by Nuvo in August 2002. The trial results confirm the efficacy of Pennsaid(R) that has been demonstrated in Nuvo's 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 (NDA) to the FDA. If approved, Pennsaid(R) will fill a major unmet need in the $6.5 billion osteoarthritis market."
Study 112 enrolled 775 patients in the U.S. and Canada with symptoms of primary osteoarthritis of the knee. Patients in this 5-arm, double-blind, 12- week trial applied a topical solution and took an oral pill. The five-arms were: 1) Pennsaid(R) plus oral placebo, 2) topical placebo (containing a small amount of DMSO for blinding purposes) plus oral placebo, 3) topical vehicle- control (containing the same concentration of DMSO as in Pennsaid(R)) plus oral placebo, 4) topical placebo plus oral diclofenac and 5) Pennsaid(R) plus oral diclofenac.
Pennsaid(R) (arm 1) was superior to placebo (arm 2) with statistically significant improvement in all three primary clinical endpoints required by the FDA: pain relief (p equals 0.019), improvement in physical function (p equals 0.046) and improved patient overall health assessment (POHA) (p less than 0.0001).
Additional results from the trial show that Pennsaid(R) (arm 1) was superior to vehicle control (arm 3) (pain, p equals 0.009; physical function, p equals 0.026; POHA, p equals 0.016). There was no difference between vehicle control (arm 3) and placebo (arm 2) indicating that DMSO alone is ineffective against the symptoms of knee osteoarthritis (p greater than 0.05). There was no difference between Pennsaid(R) (arm 1) and oral diclofenac (arm 4) for all three endpoints (p greater than 0.05). Arm 5 was included in the trial at the FDA's request to review the side effect profile of Pennsaid(R) if combined with an oral NSAID. This combination showed no increased incidence of the usual side effects, just the expected additive profiles of Pennsaid(R) alone plus oral diclofenac alone.
It is anticipated that the final data from Nuvo's Phase III long-term, open-label safety trial ("Study 112E") will be available in February 2006. The results of this study will address the safety deficiencies identified in the FDA's non-approvable letter and will form part of the NDA submission in mid 2006.
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 Markham, Ontario, with manufacturing facilities in Varennes, Quebec and Wanzleben, Germany. For more information, please visit 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.
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