The US Food and Drug Administration (FDA) has declined to approve Valeant Pharmaceutical's new drug application for efinaconazole for the treatment of onychomycosis of the toenail, the company announced today.
In a complete response letter, the FDA raised questions related to chemistry, manufacturing, and controls related to areas of the container closure apparatus, the company said.
"Valeant believes that these items can be addressed and is working for a timely response to the FDA as soon as possible. Valeant remains committed to bringing efinaconazole to market as a potential new treatment for onychomycosis," the company said in a statement.
No Efficacy, Safety Issues
Efinaconazole is a topical antifungal that is the first in the triazole class of agents to be developed for the treatment of distal lateral subungual onychomycosis. This condition presents as a subungual hyperkeratosis and onycholysis, which is usually yellow-white in color and yellow streaks and/or yellow onycholytic areas in the central portion of the nail bed.
The FDA did not raise any efficacy or safety issues in the complete response letter.
In 2 identical randomized, doubled-blind phase 3 clinical trials, complete cure rates with efinaconazole were 17.8% in study 1 and 15.2% in study 2 compared with 3.3% and 5.5%, respectively, for vehicle controls (P < .001). Complete cure was defined as 0% clinical involvement of the target toenail, as well as negative potassium hydroxide examination and fungal culture at week 52.
Mycologic cure rates (negative nail culture and microscopy results) were also significantly better with efinaconazole, at 55.2% and 53.4% compared with controls (P <. 001).
More Than 1 Issue for Company
Even if the FDA had given Valeant the go-ahead to market efinaconazole, the company was planning to postpone the product's launch until at least September 2013, company spokesperson Laurie W. Little told Medscape Medical News.
Valeant is involved in a breach-of-contract dispute with Anacor Pharmaceuticals, and although Valeant "intends to vigorously contest Anacor's claims," the company had agreed to hold off on product promotion until an arbitration hearing is completed, Little said.
Neil Osterweil contributed to this report.
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Cite this: No FDA Okay Yet for Topical Onychomycosis Drug - Medscape - May 28, 2013.