Arthritis in Joints: New type of pain relieving trandermal using DMSO solvent as the transdermal agent and Diclofenac NSAID as the active ingredient.
Nuvo's Pennsaid NDA Resubmission Accepted for Review by U.S. FDA
MISSISSAUGA, ON, July 13 /CNW/ - Nuvo Research Inc. (TSX:NRI) today
announced that it has resubmitted its New Drug Application (NDA) for
Pennsaid(R), a topical non-steroidal anti-inflammatory (NSAID) used for the
treatment of osteoarthritis of the knee to the U.S. Food and Drug
Administration (FDA). The FDA has confirmed that it has received Nuvo's
resubmission for review and has indicated that its goal date to complete its
review of the resubmission is December 28, 2006. The resubmission is a
complete Class 2 response to the deficiencies outlined in an August 2002
Non-Approvable (NA) letter issued by the FDA with respect to Pennsaid(R).
Pennsaid(R) is currently approved for sale in Canada and several European
countries.
"This resubmission is the result of significant efforts by our employees,
management and our FDA advisory board," said Dr. Henrich Guntermann, Nuvo's
President and CEO. "This NDA resubmission contains data collected from recent
efficacy and safety trials that were designed to answer the FDA's key
concerns. If approved, Pennsaid(R) will fill a major unmet need in the
$3.7 billion U.S. osteoarthritis market."
To meet the FDA's clinical efficacy and safety requirements as stated in
the 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(R) to oral diclofenac.
To address the long-term safety requirements as stated in the NA letter,
Nuvo conducted study 112E, a long-term multi-centre, single-arm safety study
of Pennsaid(R) applied by patients with symptoms of osteoarthritis (OA) 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 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 manufacturing facilities in
Varennes, Québec and Wanzleben, Germany. For more information, please visit
www.nuvoresearch.com. |
