-Expects to File Pennsaid FDA Resubmission Within 60 Days-
MISSISSAUGA, ON, Jan. 28 /CNW/ - Nuvo Research Inc. (TSX: NRI), a
Canadian drug development company focused on the research and development of
drug products delivered to and through the skin using its topical and
transdermal drug delivery technologies, today announced that it has
successfully completed all of the studies that will support the Company's
resubmission of its Pennsaid application to the United States Food and Drug
Administration (FDA). Pennsaid, a topical non-steroidal anti-inflammatory drug
(NSAID), is currently marketed in Canada and several European countries to
treat the pain and symptoms associated with osteoarthritis.
"We are confident that the results and information gathered from these
studies will provide the FDA with the data it requires to give Nuvo final,
unconditional approval to market Pennsaid in the U.S." said Dr. Henrich
Guntermann, President and CEO of Nuvo.
Nuvo is in the process of finalizing its resubmission for Pennsaid
approval, which it expects to file with the FDA within the next 60 days. Upon
acceptance of the filing, the FDA is expected to provide Nuvo with a date
under the Prescription Drug User Fee Act (the PDUFA date), by which the FDA
will advise Nuvo of its decision respecting Pennsaid's approvability. Nuvo
anticipates the PDUFA date will be six months after it files its Pennsaid
Nuvo's resubmission is a complete response amendment to an approvable
letter for Pennsaid received from the FDA in December of 2006. In that letter,
the FDA confirmed that Pennsaid could be approved for sale in the U.S. once
certain conditions were satisfied. None of the conditions relate to clinical
efficacy or clinical safety of Pennsaid, which were evidenced in Nuvo's Phase
3 clinical trials, and the FDA has not requested that Nuvo conduct any
additional clinical efficacy or safety trials.
The conditions in the approvable letter relate to the proposed Pennsaid
bottle, the potential interaction of Pennsaid with other topical products and
the requirement that Nuvo conduct pre-clinical studies to support the dermal
safety of Pennsaid.
Nuvo believes that the completed studies, announced today, support the
safety of the Pennsaid bottle, and provide the specific information identified
by the FDA as needed to support the safe use of Pennsaid with other topical
products. In addition, and as requested by the FDA, Nuvo has completed two
pre-clinical repeat dose dermal toxicology studies in animals (the "Dermal Tox
Studies"), both of which support Pennsaid's safety.
The FDA previously confirmed in written meeting minutes that a two-year
dermal carcinogenicity study in animals (the "Dermal Carcinogenicity Study")
could be completed and submitted to the FDA post approval provided that the
Dermal Tox Studies did not show signals of safety concern. Nuvo believes that
there are no such signals in the Dermal Tox Studies and intends to complete
and submit the Dermal Carcinogenicity Study post approval as per its agreement
with the FDA.
Pennsaid is a topical non-steroidal anti-inflammatory drug used for the
treatment of osteoarthritis. Pennsaid allows the active ingredient,
diclofenac, to be delivered to a specific site via the surface of the skin and
thus limits 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. There are
more than 27 million Americans suffering from osteoarthritis, a very painful
and debilitating condition, and the United States market for this condition is
estimated at US$4 billion annually.
About Nuvo Research Inc.
Nuvo is focused on the research and development of drug products
delivered to and through the skin using its topical and transdermal drug
delivery technologies. Nuvo's lead product is Pennsaid, a topical
non-steroidal anti-inflammatory used for the treatment of osteoarthritis. Nuvo
intends to leverage its skin-penetrating technologies to create a portfolio of
topical and 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 and a research and development Center
in San Diego California. For more information, please visit
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