The company had hoped that the phase III trial would prove Hyphanox to be as effective as the leading treatment for vaginal candidiasis, commonly known as vaginal yeast infection. The study compared a single dose of Hyphanox to a single dose of fluconazole, the approved treatment for such infections.
Fluconazole is marketed under the brand name Diflucan by Pfizer. Generic copies of the drug are also available through other companies.
The multi-center study investigated vaginal candidiasis in over 1200 patients. Around 26% of participants treated with Hyphanox were cured of infection compared to 37% of those treated with fluconazole.
Hyphanox is a 200mg tablet formulation of itraconazole, an antifungal agent that is used in the treatment of various fungal infections. Barrier intends investigate the potential of Hyphanox as a treatment of onychomycosis also known as common nail fungus.
Dr Geert Cauwenbergh, chairman and CEO of Barrier said: “We will continue to analyze the massive amount of data to determine next steps for this indication. The results from this single dose study for vaginal candidiasis do not affect our confidence in the potential of Hyphanox for the chronic treatment of onychomycosis, for which the active ingredient, itraconazole, is currently approved in the United States. We will of course also continue to pursue the development of the seven other important product candidates in our clinical pipeline.”