NexMed (NEXM) says new drug application will not be submitted to FDA.
Shares of New Jersey-based NexMed (NASDAQ: NEXM, Stock Forum) plunged more than 80% Wednesday morning to 25 cents after the company reported after Tuesday’s market close that a new drug application will not be submitted to the U.S. Food and Drug Administration at this time for its NM100060 drug for the treatment of onychomycosis, or nail fungus.
The drug is a topical application of terbinafine formulated with NexACT(R) for the treatment of onychomycosis. The decision was based on First Interpretable Results of Phase III clinical studies, says the company, and the two NM100060 clinical studies were randomized, double-blind and placebo-controlled, and “designed to assess the efficacy, safety and tolerability of NM100060 in patients with mild to moderate toenail onychomycosis.” NexMed says no significant adverse event was reported in the studies.
The company entered into an agreement with Novartis in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.
"While this is disappointing," said Vivian Liu, NexMed's president and chief executive officer, "a European comparator study is still ongoing, and those results are expected mid 2009."
