Stiefel Completes Phase-III Clinical Trial For Hyphanox

Stiefel has declared the completion and analysis of phase III clinical trial for Hyphanox (itraconazole) tablets, for the treatment of onychomycosis.

The study compared once daily oral dosing of one 200mg Hyphanox tablets to two 100mg capsules of itraconazole taken once a day for three months for the treatment of onychomycosis.

Results from the clinical trial indicated that 22.3% of subjects treated with Hyphanox tablets reached the primary endpoint, as compared to 21.7% of the itraconazole capsules and 1% of the placebo-treated subjects.

The company intends to use the clinical information to support a new drug application with the FDA.

Gavin Corcoran, Chief Scientific Officer at Stiefel, said: The completion of this trial is an important milestone in the development of this formulation and we are grateful for the efforts of all the investigators involved in this pivotal study.