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Valeant Announces Successful Results From Phase III Onychomycosis Trials
Date:12/16/2011

MISSISSAUGA, Ontario, Dec. 16, 2011 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced successful results from two large international Phase 3 studies of its topical investigational drug {efinaconazole (IDP-108)} product for the treatment of mild to moderate onychomycosis of the toenail. In both the studies, the investigational drug product was found to be statistically superior (p<0.001) to placebo for all primary and secondary endpoints. It was found to be generally safe and well tolerated.

Efinaconazole is an investigational antifungal drug belonging to the triazole family. The investigational drug product has not been found by the U.S. Food and Drug Administration (FDA) to be safe or effective for the treatment of mild to moderate onychomycosis of the toenail and may not be sold or promoted in the United States unless the FDA has approved a new drug application. Similar restrictions apply in other countries. 

Valeant holds an exclusive license from Kaken Pharmaceutical Co., Ltd., to commercialize efinaconazole in North America, Central America, South America and the European Union.

About Onychomycosis

Onychomycosis (also known as "dermatophytic onychomycosis" and "tinea unguium") is a fungal infection that affects the nail and nail bed. The prevalence of onychomycosis is about 6-8% in the adult population. It is the most common disease of the nail and constitutes about a half of all nail abnormalities. Without treatment, the nails thicken and cause localized pressure-related pain. Dermatophytes are the primary fungi that cause onychomycosis.

About Valeant

Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops and markets a broad range of pharmaceutical products primarily in the ar
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SOURCE Valeant Pharmaceuticals International, Inc.
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