MISSISSAUGA, ON, June 28, 2011 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a
specialty pharmaceutical company dedicated to building a portfolio of
products for the topical treatment of pain, today announced that the
U.S. Food and Drug Administration (FDA) has cleared the Company's
Investigational New Drug (IND) application filed May 27, 2011 for a
novel topical Lidocaine Spray formulation (NRI-ANA), allowing for
initiation of Phase 1 studies.
NRI-ANA is being developed for the treatment of an acute neuropathic
pain condition using molecular skin penetration enhancers identified by
Nuvo scientists. These transdermal carriers deliver the active drug
through the skin directly to the site of pain, potentially offering
site-specific pain therapy while limiting systemic exposure with the
potential to reduce negative side effects, adverse events and potential
drug-drug interactions. International patent applications are pending.
Clearance of the NRI-ANA IND provides Nuvo with an additional
development option as it completes a thorough review of its internally
developed pain pipeline product candidates, as well as those recently
acquired through the acquisition of ZARS Pharma, Inc. The Company is
actively prioritizing these product pipeline opportunities based on
several criteria and will provide additional information on pipeline
decisions after a comprehensive evaluation.
NRI-ANA is a novel, spray formulation of lidocaine designed to allow
application of the product without the need to touch the skin.
Patients with neuropathic pain often suffer from allodynia, a common
disabling symptom in which normally non-painful touch can result in
pain. A spray formulation may be advantageous in certain patients as
the drug can be delivered without the need to touch the skin, leading
to a more comfortable experience and potentially enhanced
compliance.The product currently has international patents pending.
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical
company, headquartered in Mississauga, Ontario. The Company is
building a portfolio of products for the treatment of pain through
internal research and development and by in-licensing and acquisition.
The Company's Pain Group, located in West Chester, Pennsylvania, is
focused on the development and commercialization of topically delivered
pain products. The Company's product portfolio includes Pennsaid,
Pliaglis and Synera. Pennsaid, a topical non-steroidal
anti-inflammatory drug (NSAID), is used to treat the signs and symptoms
of osteoarthritis of the knee. Pennsaid is sold in the United States
by Mallinckrodt Inc., a Covidien company (NYSE: COV), in Canada by
Paladin Labs Inc. (TSX:PLB) and in several European countries. Pliaglis
is a topical local anesthetic cream, which is U.S. Food and Drug
Administration (FDA) approved to provide topical local analgesia for
superficial dermatological procedures. The Company has licensed
worldwide marketing rights to Pliaglis to GaldermaPharma S.A., a global
specialty pharmaceutical company focused on dermatology. Synera is a
topical patch that combines lidocaine, tetracaine and heat, approved in
the United States to provide local dermal analgesia for superficial
venous access and superficial dermatological procedures and in Europe,
for surface anaesthesia of normal intact skin. Nuvo currently markets
Synera in the United States and its licensing partner, EuroCept
International B.V., has initiated a pan-European launch of Synera
(under the name Rapydan) in several European countries. Through its
subsidiary, Nuvo Research GmbH, based in Leipzig, Germany, the Company
is also developing the compound WF10, for the treatment of immune
related diseases. For more information, please visit www.nuvoresearch.com.
This document contains forward-looking statements. Some forward-looking
statements may be identified by words like "expects", "anticipates",
"plans", "intends", "indicates" or similar expressions. These
forward-looking statements, by their nature, necessarily involve risks
and uncertainties that could cause actual results to differ materially
from those contemplated by the forward-looking statements. Nuvo
considers the assumptions on which these forward-looking statements are
based to be reasonable at the time they were prepared, but caution that
these assumptions regarding future events, many of which are beyond the
control of the Company, may ultimately prove to be incorrect. Factors
and risks, which could cause actual results to differ materially from
current expectations, are discussed in the annual report, as well as in
Nuvo's Annual Information Form for the year ended December 31, 2010.
Nuvo disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information or
future events, except as required by law. For additional information on
risks and uncertainties relating to these forward looking statements,
investors should consult the Company's ongoing quarterly filings,
annual report and Annual Information Form and other filings found on
SEDAR at www.sedar.com.
SOURCE Nuvo Research Inc.