WOODCLIFF LAKE, N.J., Sept. 14 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. , today announced that its development partner BioAlliance Pharma SA presented Phase III study results for miconazole Lauriad(R) mucoadhesive buccal tablets (MBT) that demonstrate noninferiority to clotrimazole troches for oropharyngeal candidiasis (OPC), an opportunistic infection of the mouth and throat. The data from this study, the largest study to date conducted in OPC, were presented in an oral presentation to attendees at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. More than 10,000 physicians, researchers and other healthcare professionals from around the globe gather each year at ICAAC to foster worldwide solutions to the problem of infectious diseases.
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.
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.
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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.
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Par Pharmaceutical Companies, Inc.
