FDA Accepts Drug Application for Miconazole Lauriad to Treat Oropharyngeal Candidiasis

StrativaPharmaceuticals, the proprietary products division of a wholly ownedsubsidiary of Par Pharmaceutical Companies, Inc. has announcedthat the FDA has accepted the new drugapplication (NDA) for miconazole Lauriad mucoadhesive buccal tablets (MBT) totreat oropharyngeal candidiasis (OPC). Miconazole MBT delivers the antifungalmiconazole via a mucoadhesive buccal tablet that is designed to enableonce-daily dosing of the active ingredient at the site of infection. The NDA submission was based primarily on data from a Phase III studydemonstrating noninferiority to Mycelex Troche (clotrimazole)… in thecomplete resolution of signs and symptoms of OPC. The randomized,double-blind, double-dummy study was conducted in 577 HIV-positive patients in40 sites in the United States, Canada, and South Africa. “The NDA acceptance of miconazole MBT represents a significant milestonefor Strativa Pharmaceuticals as this would be the first oral miconazoletherapy available in the U.S. and would provide healthcare providers with anew option for treating OPC,” said John A. MacPhee, president of StrativaPharmaceuticals. “We believe miconazole MBT’s delivery system and once-dailydosing schedule will offer an effective, convenient alternative to currentlyavailable local therapies, which require several doses per day to treat OPC.”Strativa could launch miconazole MBT in the second half of 2010, if approved.OPC, familiarly known as thrush, is an oral fungal infection most commonin individuals with weakened immune systems — particularly those withHIV/AIDS and those undergoing cancer treatments. OPC is a disruptivecondition that results in lesions and inflammation in the mouth, and includessymptoms such as soreness, burning and/or altered taste. Miconazole MBT was approved in 11 countries and is currently beingmarketed in several EU territories including France, Germany and the UK underthe trade name Loramyc . While miconazole MBT would be the first miconazoletreatment available in oral form in the U.S., other dosage forms of miconazolehave been marketed around the world. Under a licensing agreement withBioAlliance Pharma SA, Strativa is the exclusive U.S. distributor ofBioAlliance’s miconazole MBT. Upon FDA approval of the product, Strativa willpay BioAlliance $20 million, as well as a royalty on future net sales.BioAlliance may also be entitled to milestone payments if net sales achievespecified targets.