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Valeant Pharmaceuticals Announces Publication of Efinaconazole Phase III Results
Date:11/26/2012

lts from the two Phase III studies of efinaconazole with the publication by a leading dermatology journal," stated J. Michael Pearson, chairman and chief executive officer.  "While oral treatment of onychomycosis has been the standard of care, drug interactions and risk of acute liver injury may limit their use especially in older adults where disease is most prevalent, those on multiple drug regimens, or for patients or doctors who prefer topical therapies. As no new onychomycosis treatments have been introduced for over 10 years, we believe in the authors' conclusion that this may be the first topical treatment option for DLSO that can be considered a viable alternative to oral treatments."

"This is a very exciting time for patients with the pending launch of the first new topical anti-fungal treatment approved in more than a decade," said Boni Elewski, MD Professor of Dermatology, University of Alabama.  "Onychomycosis is a common infection that, left untreated, can later appear not only on other toes and fingers, but also on friends and family, too. It is estimated that one in ten Americans suffer from onychomycosis, which causes the nail to thicken and can be quite painful, making this condition more than just a cosmetic problem.  Furthermore, as some research indicates that up to half of patients over the age of 70 suffer from this progressive disease. An effective topical therapy like efinaconazole is a logical treatment option to avoid drug interactions and systemic side effects, as these patients undoubtedly take other oral medications."

For the complete article, please go to http://www.jaad.org.

Trial Design

The two large, international, multicenter, randomized, double-blind, vehicle-controlled studies were conducted in subjects with onychomycosis affecting at least one great toenail. The toenail was required to have at least 20-50% of clinical involvement.  Study 1 had 870
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SOURCE Valeant Pharmaceuticals International, Inc.
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