FDA Approves Topical Antifungal for Toenails
In June, Valeant Pharmaceuticals International Inc. announced FDA approval for their medication Jublia, or efinaconazole. The topical solution is approved for the treatment of toenail onychomycosis as a result of either Trichophyton rubrum or Trichophyton mentagrophytes.
According to the product label, applying the medication daily for 48 weeks resulted in either a nearly full or a full cure in 25% of adults who used the medication in two placebo-controlled studies. The topical solution is clear to pale yellow in color. Each gram of medication contains 100 mg of the active ingredient.
Over the course of the studies, the most common side effects reported were: ingrown toenail, pain at the application site, dermatitis at the application site, and vesicles at the application site. These side effects were seen in patients who used the medication for at least 24 weeks, and were reported in less than 2.3% of patients participating in the studies. In clinical trials, no differences in terms of safety or effectiveness were shown between the older (between the ages of 65 and 74) participants and the younger participants.
The instructions for use indicate patients should apply a single drop of the solution to the affected toenail, unless it is the big toenail, and in that case, a second drop should be applied on the end of the nail. Using the brush attached to the medicine bottle, patients should then spread the medication across the entire toenail, the cuticle, and any skin next to and underneath the nail.
Nails should be clean and dry before application. Patients are advised to wait at least 10 minutes after showering or bathing before applying the topical treatment. Only one application per day is required. Patients are advised to avoid the use of nail polish, pedicures, and other cosmetics on the nails and feet during the course of treatment.
If at any time a patient experiences redness, swelling, or persistent irritation, the patient should notify his or her doctor or pharmacist right away. Women who are pregnant should not use this medication unless told to do so by their doctor. Women who are nursing should exercise care when using this medication, as it is not known whether this medication will transfer through breast milk.
The medication will be distributed in plastic bottles that contain either 4 mL or 8 mL of 10% efinaconazole solution. Since the medication contains alcohol, it is flammable and should be not kept near any areas where children can easily access it. The bottle should be stored at room temperature, in an upright and tightly closed position.
The new product should be made available for prescription during the third quarter of 2014.