BioAlliance announces Phase III results of miconazole Lauriad MBT for treatment of oropharyngeal candidiasis

Sep 14 2009

Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), 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.

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."