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news.Barrier Therapeutics has completed patient enrollment for its pivotal Phase III clinical study of Hyphanox, an oral formulation of the antifungal agent itraconazole, for the treatment of toenail onychomycosis.
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The trial is designed to study the effect of Hyphanox 200mg tablets taken once a day orally for three months. Efficacy is defined as both complete clinical and mycological cure of the toenail fungal infection at nine months following end of treatment.
Geert Cauwenbergh, CEO said: “The completion of enrollment in this trial is another important milestone, as we continue to advance our pipeline of product candidates that target large market opportunities in dermatology. We believe that Hyphanox has the potential to be an effective oral treatment for onychomycosis, providing patients with a more convenient dosing form and offering Barrier Therapeutics a potential entry into one of the largest disease categories in dermatology.”
Dr Braham Shroot, CSO said: “This study, which we believe is the largest randomized controlled clinical study in onychomycosis ever undertaken, further demonstrates Barrier’s commitment to bring innovative treatments to dermatologists and their patients. Based on the study protocol, the last patient should complete the study in September of next year and we expect to announce top-line results during the fourth quarter of 2008.”