The US Food and Drug Administration (FDA) has approved efinaconazole 10% topical solution (Jublia, Valeant Pharmaceuticals) for the treatment of onychomycosis of the toenail, the company announced June 9.
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.
The FDA declined to approve efinaconazole for onychomycosis in May 2013, as reported by Medscape Medical News, citing questions related to chemistry, manufacturing, and controls related to areas of the container closure apparatus. The agency had no efficacy or safety concerns at that time.
Efinaconazole is applied daily to the nail with a novel bottle that has a built-in flow-through brush applicator. It dries quickly, and there is no need to remove excess product, the company says.
Efinaconazole was studied in 2 identical randomized, doubled-blind phase 3 clinical trials involving 1655 patients with onychomycosis.
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).
Adverse events that were reported were generally mild and transient and were similar between patients treated with efinaconazole and those treated with vehicle controls. The most commonly reported adverse events in patients treated with efinaconazole were application site dermatitis and application site vesicles. There are no concerns for systemic adverse effects such as drug–drug interactions or acute liver injury, according to the company.
An estimated 35 million Americans suffer from onychomycosis, most of whom are men between 50 and 70 years of age. The condition typically begins as a small white or yellow spot beneath the nail and causes nail discoloration, thickening and/or distortion, pain, detachment of the nail bed, and irregular surface changes.
Onychomycosis is untreated in most patients largely because of limitations in available treatments, the company notes in a statement.
"Onychomycosis is not only embarrassing and uncomfortable, but can lead to permanent nail damage and limited mobility in the general population," Glenn B. Gastwirth, DPM, executive director and chief executive officer of the American Podiatric Medical Association, said in the statement.
"We welcome the approval of Jublia and encourage people with onychomycosis of the toenails to discuss their condition with their podiatrist, or other healthcare professional to find a treatment that's right for them," he said.
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Cite this: FDA OKs First Topical Triazole Antifungal for Onychomycosis (Jublia) - Medscape - Jun 10, 2014.