WOODCLIFF LAKE, N.J. The proprietary products division of a generic drug maker got favorable results from a clinical trial of a drug for treating an opportunistic infection of the mouth and throat.
Strativa Pharmaceuticals, part of Par Pharmaceutical Cos., said a phase 3 trial of Lauriad (miconazole) mucoadhesive buccal tablets showed that they worked as well as clotrimazole troches in treating oropharyngeal candidasis. Data from the study were presented at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco.
In the study, patients with HIV and AIDS were treated with a 50 mg dose of Lauriad once a day or a 10 mg troche of clotrimazole five times a day for the treatment of OPC. Results showed no significant difference between the drugs in terms of efficacy.
Strativa could make the drug available in the United States through a licensing agreement with BioAlliance Pharma in the second half of 2010 if it receives approval from the Food and Drug Administration, Strativa said.