RxTrials Institute Drug Pipeline Alert

Based on results from Phase III clinical studies for NM100060, a topical application of terbinafine formulated with NexACT for the treatment of onychomycosis, NexMed will not submit an NDA to the FDA.

The two randomized, double-blind, placebo-controlled studies assessed the efficacy, safety and tolerability of the drug in patients with mild-to-moderate toenail onychomycosis, or nail fungus. No significant adverse event was reported in the studies.

The company says in a statement it expects to receive results from an EU comparator study by the middle of next year.