Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc, announced that its development partner BioAlliance Pharma SA presented phase-III study results for miconazole Lauriad 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.

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 US Food and Drug Administration (FDA). If approved, Strativa, the exclusive US distributor of miconazole MBT under a licensing agreement with BioAlliance Pharma SA, could make miconazole MBT available in the US in the second half of 2010. While approved in 12 countries and marketed in several EU territories under the trade name Loramyc, miconazole MBT would be the first miconazole oral therapy available in the US.

"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.

Strativa Pharma 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.

Par Pharma develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.

BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV.