MISSISSAUGA, ON, June 5 /CNW/ - Nuvo Research Inc. (TSX: NRI) today
announced that it is continuing discussions with the U.S. Food and Drug
Administration ("FDA") to clarify and resolve matters raised by the FDA in its
approvable letter (the "Approvable Letter") for Pennsaid issued on
December 28, 2006. The discussions primarily concern the FDA's requirements
for data to evidence the dermal safety of Pennsaid and its constituent
components. While these discussions are ongoing, no definitive agreement has
been reached with the FDA at this time. The Company will provide further
updates as the steps toward Pennsaid approval are clarified.
In the Approvable 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 III trials. The FDA has not requested
that Nuvo conduct any additional Phase III clinical trials.
Pennsaid(R) is a topical non-steroidal anti-inflammatory drug (NSAID) for
the treatment of osteoarthritis and is currently approved for sale in Canada
and several European countries. Pennsaid(R) allows the diclofenac solution to
be delivered to a specific site via the surface of the skin. The systemic
exposure of Pennsaid is approximately 1/200th of that from the oral dosage
form of diclofenac, greatly decreasing the potential for complications
associated with the oral route of delivery. According to published clinical
trials, Pennsaid(R) 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 is currently no
topical NSAID product approved in the approximately $4 billion U.S.
osteoarthritis pain relief market. In December 2006, the U.S. Food and Drug
Administration issued an Approvable Letter that indicated Pennsaid(R) is
approvable subject to Nuvo satisfying certain conditions.
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
drug (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 and a research and development facility in San Diego,
California. 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.
For further information:
For further information: Investor Relations: Christina Bessant, Equicom
Group Inc., (416) 815-0700 x269, firstname.lastname@example.org