CORAL GABLES, Fla., June 2 /PRNewswire/ -- Stiefel Laboratories, Inc. announced the completion and analysis of a pivotal phase III clinical trial for Hyphanox(TM) (itraconazole) tablet. The 200 mg itraconazole tablet formulation was developed using the proprietary Meltrex(R) technology.
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 Gavin Corcoran, chief scientific officer, Stiefel.
Barrier Therapeutics was acquired by Stiefel Laboratories in August 2008. The acquisition broadened Stiefel's extensive product offering by adding three premium prescription products, making a wider range of treatment options available to physicians and patients under the Stiefel umbrella. In addition, the acquisition of the Barrier drug portfolio deepened an already strong Stiefel pipeline of products by adding several promising novel product candidates.
"The successful acquisition of Barrier Therapeutics provided strategic access to many important development programs like Hyphanox(TM)," said Bill Humphries, president, Stiefel. "We look forward to the opportunity to bring this important product to market and add to our physician's options for treating their patients."
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 the United States, onychomycosis is estimated to affect up to 35 million people.
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 $100 million USD in developing the most advanced skin health solutions. Additionally, Stiefel supplements its research and development efforts by seeking strategic partnerships and acquisitions around the world. To learn more about Stiefel, visit www.stiefel.com.
The Meltrex(R) technology was developed by SOLIQS, the global drug delivery business of Abbott GmbH & Co. KG, Germany. Meltrex(R) is a worldwide registered trademark of Abbott.
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