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FDA Rejects Nail Infection Drug Efinaconazole

Agency faults product container (May 28)

The FDA’s Center for Drug Evaluation and Research has issued a complete response letter (CRL) regarding the new drug application (NDA) for efinaconazole solution 10% (Valeant Pharmaceuticals International, Inc.) for the treatment of onychomycosis. The agency issues a CRL when the review of a file is completed but questions remain that preclude the approval of the NDA in its current form.

The questions raised by the FDA pertaining to efinaconazole involve the product’s container closure apparatus. No efficacy or safety issues were raised.

In November 2012, positive results were reported from two pivotal, randomized, double-blind, vehicle-controlled trials of efinaconazole in a total of 1,655 subjects with onychomycosis. The primary endpoint of both studies was the complete cure rate (defined as no clinical involvement and no evidence of fungus present by both KOH [potassium hydroxide] testing and a negative fungal culture) at week 52.

In the first study, 17.8% of subjects treated with efinaconazole were completely cured, compared with 3.3% of subjects treated with vehicle. Similarly, in the second study, 15.2% of subjects treated with efinaconazole were completely cured, compared with 5.5% of subjects treated with vehicle. Using the secondary endpoint of a complete or almost complete cure (defined as ≤ 5% clinical involvement and 100% mycologic cure), the success rates for efinaconazole were 26.4% and 23.4%, respectively.

Sources: Valeant; May 28, 2013; and Valeant; November 26, 2012.

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