Healthcare Industry News: Transdermal
News Release - January 31, 2007
NexMed Announces Patient Dosing in Phase 3 Program for Anti-Fungal ProductEAST WINDSOR, NJ--(Healthcare Sales & Marketing Network)--Jan 31, 2007 -- NexMed, Inc. (NasdaqCM:NEXM ), a developer of innovative Transdermal treatments based on the NexACT® drug delivery technology, today announced that its collaborator, Novartis, has commenced dosing of patients in the Phase 3 clinical trials for NM100060, a topical treatment for onychomycosis (nail fungus). NexMed signed an exclusive, worldwide licensing agreement with Novartis in September 2005, under which Novartis has assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.
The Phase 3 program for NM100060 consists of two pivotal, randomized, double-blind, placebo-controlled studies. The parallel group studies are designed to assess the efficacy, safety and tolerability of NM100060 in patients with mild to moderate toenail onychomycosis. Approximately 1,000 patients will participate in the two studies, which will take place in the U.S., Europe, Canada and Iceland.
NM100060 is a topical application of Lamisil® (terbinafine), formulated with terbinafine and the NexACT permeation enhancer, which facilitates the delivery of the drug into the nail bed where the fungus resides.
Onychomycosis is a fungal infection affecting the toenails and/or fingernails. It is one of the most common dermatological diseases, affecting an estimated 30 million people in the U.S. alone. Nail fungus can be painful, embarrassing, expensive and difficult to treat. A 1998 American Journal of Dermatology article estimated costs of monitoring and treatment of nail fungus ranged $700 to $1,200 per patient annually.
About the NexACT Technology
NexMed's NexACT Transdermal drug delivery technology is designed to overcome the skin's natural barriers, enabling high concentrations of active drugs to rapidly penetrate the skin. The technology's cellular mechanism of action has shown to increase the permeability of the cell membrane in a time and concentration-dependent manner. NexACT may offer significant clinical benefits in cases where low bioavailability, multiple daily dosing, liver first pass effect, or GI side effects are associated with oral or injectable dosage forms of a particular drug. For drugs with a narrow therapeutic index, NexACT may provide a controlled rate of administration, which is a significant advantage for maintaining efficacy while reducing toxicity.
About NexMed, Inc.
NexMed, Inc. is an emerging drug developer that is leveraging its proprietary NexACT skin permeation, drug delivery technology to develop a significant pipeline of innovative pharmaceutical products to address significant unmet medical needs. The Company is also exploring opportunities with various pharmaceutical companies to incorporate NexACT into their existing drugs as a means of developing new patient-friendly Transdermal products and extending patent lifespans and brand equity. NexMed currently has a host of medicines in development, such as treatments for nail fungus, sexual disorders and more, all based on its proprietary NexACT drug delivery technology.
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