NUVO RECEIVES IND CLEARANCE FROM FDA TO BEGIN CLINICAL TESTING OF LIDOCAINE SPRAY
June 28, 2011
MISSISSAUGA, ON, June 28, 2011 /CNW/ - 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.
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