The FDA has approved Oravig (miconazole buccal tablets, from Strativa) for the treatment of oropharyngeal candidiasis (OPC) in patients ≥16 years of age. This approval was based on data from two Phase 3 clinical trials. The first study, a multicenter, randomized, double-blind, double-dummy trial, demonstrated that Oravig completely resolved signs and symptoms of OPC at rates similar to Mycelex Troche (clotrimazole, from Ortho-McNeil) in 577 HIV-positive patients. A second randomized, open-label, multicenter comparative trial conducted in 282 patients who underwent radiotherapy for head and neck cancer showed that Oravig is safe and effective in this patient population who often has reduced salivary flow.
Oravig buccal tablets adhere to the gum and deliver miconazole directly at the local site of infection throughout the day with minimal systemic absorption. Oravig will be available in a 50mg dosage strength as a flavorless, odorless buccal tablet. It is expected to be made available in the third quarter of 2010.
For more information call (201) 802-4000 or visit www.strativapharma.com.