FDA has accepted the new drug application (NDA) from Strativa Pharmaceuticals, the proprietary products division of a wholly-owned subsidiary of Par Pharmaceutical, for miconazole Lauriad mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC).
Miconazole MBT delivers the antifungal miconazole via a mucoadhesive buccal tablet that is designed to enable once-daily dosing of the active ingredient at the site of infection.
Reportedly, the NDA submission was based primarily on data from a phase III study demonstrating noninferiority to Mycelex Troche (clotrimazole) in the complete resolution of signs and symptoms of OPC.
John MacPhee, president of Strativa Pharmaceuticals, said: The NDA acceptance of miconazole MBT represents a significant milestone for Strativa as this would be the first oral miconazole therapy available in the US and would provide healthcare providers with a new option for treating OPC.
We believe miconazole MBT’s delivery system and once-daily dosing schedule will offer an effective, convenient alternative to currently available local therapies, which require several doses per day to treat OPC, he added.