ICAAC: Positive preliminary results of new luliconazole formulation in onychymycosis trial

Luliconazole, a medication approved in Japan for the treatment of superficial mycosis in a 1% formulation, was not associated with any serious side effects when used in a 10% formulation to treat toenail fungus, reports The Pharma Letter’s correspondent at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, USA.

Luliconazole was discovered by Japanese agrochemical firm Nihon Nohyaku and was approved and launched in Japan in 2005. In 2010 it was launched as Lulifin in the Indian dermatology market ( The Pharma Letter January 5, 2010).

According to the poster presentation, 97.8% of the tolerability assessments in the Phase II/III trial found no burning, stinging, pruritis, scaling, or erythema. While the researchers could not present comparative efficacy data because the study is still blinded, the poster did describe the in vitro efficacy of the compound against clinical fungal isolates. Other abstracts presented at the meeting described results of the 10% formulation achieved in in vitro and ex vivo nail models.