Stiefel Laboratories Reaps First Fruits of Barrier Acquisition With Completion of Pivotal Phase III Clinical Trial for 200 mg Hyphanox(TM) (Itraconazole) Tablet
This trial is the largest randomized controlled clinical study in onychomycosis ever undertaken.
The study compared once-daily oral dosing of one 200 mg Hyphanox(TM) tablet to two 100 mg capsules of itraconazole taken once a day for three months for the treatment of onychomycosis. Stiefel enrolled 1,381 patients in this multi-center, multi-national trial. The primary efficacy endpoint was defined as both complete clinical (IGA) and mycological cure of the toenail fungal infection at nine months following end of treatment. Hyphanox(TM) tablets demonstrated non inferiority to itraconazole capsules.
Results from this pivotal clinical trial indicated that 22.3% of subjects treated with Hyphanox(TM) tablets reached the primary endpoint as compared with 21.7% of the itraconazole capsules and 1% of the placebo-treated subjects. Mycological cure (negative microscopic examination and negative culture) was achieved by 44%, 37% and 6% of the Hyphanox(TM) tablets, itraconazole capsules and placebo treated subjects, respectively. Both treatments were well tolerated and had similar safety profiles. The company intends to use this clinical information to support a new drug application with the FDA, which is expected to be filed in the first quarter of calendar year 2009.
“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,” said
Barrier Therapeutics was acquired by Stiefel Laboratories in
“The successful acquisition of Barrier Therapeutics provided strategic access to many important development programs like Hyphanox(TM),” said
Onychomycosis is a chronic and recurring fungal infection of the toenails or the fingernails resulting in thickening and discoloration of the nail. Without treatment, the disease sometimes can result in pressure, irritation, serious pain and disability. In
About Stiefel Laboratories, Inc.
Stiefel Laboratories is enthusiastically committed to advancing dermatology and skin science around the world. The company’s deeply-rooted dedication and drive for innovation along with its sole focus on dermatology has led Stiefel to become the largest independent dermatology company in the world. In addition to more than 30 wholly-owned subsidiaries, six manufacturing plants and a global research and development network, Stiefel’s most valuable asset is its global network of nearly 4,000 driven associates.
By combining expertise, knowledge and imagination, Stiefel delivers exceptional ethical, over-the-counter and aesthetic products to its customers in more than 100 countries around the world, ultimately providing a unique Stiefel skin health experience. Stiefel also is committed to improving today’s treatments and exploring tomorrow’s innovations. Each year, the company invests more than
The Meltrex(R) technology was developed by SOLIQS, the global drug delivery business of Abbott GmbH & Co. KG,
SOURCE Stiefel Laboratories, Inc.