BioAlliance Pharma Presents Results from Phase III Study of Miconazole Lauriad Bioadhesive Buccal Tablets for Treatment of Oropharyngeal Candidiasis in Head & Neck Cancer Patients
5/17/2005 Paris, France press release Business Wire (www.businesswire.com) BioAlliance Pharma, a biopharmaceutical company focused on the field of drug resistance, announced today that a randomized Phase III trial evaluating the Company's miconazole Lauriad(R) 50mg Bioadhesive Buccal Tablets in head and neck cancer patients suffering from oropharyngeal candidiasis following radiotherapy, demonstrated efficacy with 10 times less drug and on a more convenient schedule than the miconazole oral gel comparator. These results suggest definite potential for better compliance in treating oropharyngeal candidiasis in patients with altered mucosa and xerostomia. The study (Abstract #5527) of 306 patients conducted at 36 clinical sites in France and North Africa was presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. "These results represent an important medical advance for the local treatment of oropharyngeal candidiasis," said Dominique Costantini, M.D., president and CEO of BioAlliance Pharma. "Our goal is to provide physicians with an effective option for local treatment of this fungal infection that obviates the need to prescribe systemic therapies due to its enhanced potential for improved patient compliance and avoidance of systemic drug-drug interaction and development of drug resistance." Study Objectives The main objective was to demonstrate that the efficacy of the miconazole Lauriad(R) 50mg Bioadhesive Buccal Tablet administered once daily for 14 days, was not inferior to that of miconazole oral gel 500mg delivered in 4 divided doses for 14 days. Secondary objectives were to compare other efficacy criteria at days 7 and 14, and the safety [...]