MISSISSAUGA, ON, Dec. 29 /PRNewswire-FirstCall/ - Nuvo Research Inc.
(TSX:NRI) today announced that it has received an approvable letter from
the U.S. Food and Drug Administration (FDA) for Pennsaid(R) (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 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.
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
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
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.
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