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Preliminary Results Announced From Phase III Onychomycosis Trials
CORONA, Calif., Dec. 10 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today preliminary results from two Phase III trials of its topical anti-fungal therapy for the treatment of onychomycosis, or nail fungus.
Two multi-center, double blind, randomized Phase III trials compared the safety, efficacy and tolerability of the topical anti-fungal treatment in 670 patients with toenail onychomycosis. Patients were randomized into one of two treatment groups: topical anti-fungal treatment or placebo. Topical anti-fungal patches were applied to the toenail on a daily basis for 12 months. Patients were evaluated at 6, 12, 15 and 18 months, following the start of treatment.
In one trial, the topical anti-fungal treatment achieved a statistically significant greater number of complete cures, as compared to placebo. Complete cure required success on three parameters: growth of a completely clear nail, negative fungal culture and a potassium hydroxide (KOH) test, negative for the physical presence of fungus. In the second trial, the topical anti-fungal treatment arm failed to demonstrate a statistically significant greater number of complete cures, as compared to placebo. Both trials showed the topical anti-fungal treatment to be well tolerated, with a low incidence of side effects.
Watson plans to complete and review the full data analysis over the next six to eight weeks to determine next steps for the program.
Source: Watson Pharmaceuticals, Inc.