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The randomized, double-blind, double-dummy study compared the efficacy and safety of once-daily miconazole 50 mg MBT to clotrimazole 10 mg troche administered five times per day for treatment of OPC. Results showed no significant differences between miconazole MBT and clotrimazole troches in any of the clinical efficacy endpoints, including the primary endpoint of complete resolution of signs and symptoms of OPC. The study was conducted in 577 HIV/AIDS patients in 40 sites in the United States, Canada and South Africa.
Miconazole MBT -- which delivers the antifungal miconazole via a mucoadhesive buccal tablet designed to enable once-daily dosing of the active ingredient at the site of infection -- is currently undergoing review by the U.S. Food and Drug Administration (FDA). If approved, Strativa, the exclusive U.S. distributor of miconazole MBT under a licensing agreement with BioAlliance Pharma SA, could make miconazole MBT available in the U.S. in the second half of 2010. While approved in 12 countries and marketed in several EU territories under the trade name Loramyc(R), miconazole MBT would be the first miconazole oral therapy available in the U.S.
"We believe that if approved, miconazole MBT will represent an important new treatment option for immunocompromised patients and others who suffer from OPC," said John A. MacPhee, president of Strativa Pharmaceuticals. "Miconazole MBT supports our commitment to providing innovative prescription medicines that help manage complications from serious medical conditions, across a variety of therapeutic areas."
OPC, also known as thrush, is an oral fungal infection most common in individuals with weakened immune systems -- particularly those with HIV/AIDS and those undergoing cancer treatments. OPC is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, burning and/or altered taste.
About Strativa Pharmaceuticals
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for commercialization and to help ensure their success after launch. For additional information, please visit www.strativapharma.com.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.
About BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The Company develops and commercializes innovative products that address resistance issues. For press release and other company information, visit www.bioalliancepharma.com.
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Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, in Item 1A of the Company's subsequent Quarterly Reports on Form 10-Q, in other of the Company's filings with the SEC from time to time, including Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
SOURCE Par Pharmaceutical Companies, Inc.
http://www.parpharm.com
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