Novartis drops NexMed anti-fungal nail treatment

The USA's NexMed says that its marketing partner, Swiss drug major Novartis, will not submit a New Drug Application for NM100060 with the US Food and Drug Administration.

Novartis' decision was based on the first interpretable results of two Phase III clinical studies. The trials were randomized, double-blind and placebo-controlled, and designed to assess the efficacy, safety and tolerability of NM100060, a topical application of terbinafine based on NexMed's proprietary drug-delivery technology NexACT, in patients with mild-to-moderate toenail onychomycosis (nail fungus). No significant adverse events were reported in the studies.

"While this is disappointing," said Vivian Liu, NexMed's chief executive, "a European comparator study is still ongoing, and those results are expected mid-2009." NexMed shares sank 70.6% to $0.40 in after hours trading on the day of the news, August 26.