GREENSBORO, N.C.--(EON: Enhanced Online News)--Merz North America (U.S. affiliate of the global Merz Pharma Group) today announced the nationwide availability of Naftin® (naftifine HCl) Gel 2%, which was recently approved by the U.S. FDA for the treatment of interdigital-type tinea pedis.
Naftin® (naftifine HCl) is the #1 topical antifungal brand prescribed by dermatologists and podiatrists in the U.S.1 Naftin® (naftifine HCl) Gel 2% improves on the original formulation of Naftin® (naftifine HCl) Gel 1% by delivering the efficacy of naftifine hydochloride with a once-daily application treatment regimen. In clinical studies, Naftin (naftifine HCl) Gel 2% demonstrated continuous improvement in post-treatment efficacy rates for up to four weeks after treatment regimen had ended.
“We are pleased to be able to provide physicians and their patients with a new option for the safe and effective treatment of interdigital-type tinea pedis. Merz remains committed to advancing the quality of care in the medical dermatology space, and we believe the launch of Naftin® (naftifine HCl) Gel 2% is evidence of our ongoing leadership in the topical antifungal category,“ said Greg Besase, Vice President and Head of US Dermatology for Merz North America.
Naftin® (naftifine HCl) Gel 2% is an allylamine antifungal that treats interdigital-type tinea pedis by killing a fungus called Trichophyton rubrum, the organism that causes most fungal infections. Tinea pedis is the most common chronic fungal infection in the world. It is a skin infection that is usually found between the toes and is often found on the bottom or sides of the feet. If left untreated, it can spread to the toenails or other parts of the body. In clinical trials, Naftin® (naftifine HCl) Gel 2% exhibited fungicidal activity against a broad spectrum of dermatophytes, as well as clinically significant anti-bacterial and anti-inflammatory effects.
About Naftin Gel 2%
Naftin (naftifine HCl) Gel 2% is an allylamine antifungal that is applied topically once a day for 2 weeks. In clinical studies, Naftin (naftifine HCl) Gel 2% demonstrated continuous improvement in post-treatment efficacy for up to four weeks after treatment regimen had ended. The approval of Naftin® (naftifine HCl) Gel 2% is based on results from 2 pivotal U.S. clinical trials involving 47 investigational sites and included 1715 adult patients. The results indicate that patients treated with Naftin® (naftifine HCl) Gel 2% experienced clinically significant cure rates when compared to placebo.
Naftin® (naftifine hydrochloride) Gel, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 18 years of age and older. The most likely adverse reactions are application skin reactions. (2%)
About Merz North America
Merz North America is a specialty healthcare company that develops and commercializes innovative treatment solutions in aesthetics, dermatology and neurosciences in the U.S. and Canada. Our ambition is to become a recognized leader in the treatment of movement disorders, and in aesthetics and dermatology. Our future is promising, and we are committed to advancing new therapeutic options and improving patients’ lives. For more than 100 years, the development of Merz products has been based on our commitment to providing innovative medical approaches that earn trust of patients, physicians and partners worldwide. Globally, the companies of Merz Pharma Group are focused on medications for treating neurological and psychiatric illnesses, and they have assumed a leading role in the field of Alzheimer’s disease research. Founded in 1908, Merz Pharma Group is a privately-owned company headquartered in Frankfurt, Germany.
IMPORTANT SAFETY INFORMATION for ONMEL™, INCLUDING BOXED WARNING
|WARNING: CONGESTIVE HEART FAILURE, CARDIAC EFFECTS AND DRUG INTERACTIONS|
Do not administer ONMEL™ for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen. If signs or symptoms of congestive heart failure occur during administration of ONMEL™, discontinue administration.
Drug Interactions: Co-administration of cisapride, pimozide, quinidine, dofetilide, levacetylmethadol (levomethadyl), felodipine, oral midazolam, nisoldipine, triazolam, lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) or methadone with ONMEL™ is contraindicated. ONMEL™, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), methadone or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors.
1 IMS Health, NPA June 2012