February 2013

Phase III Studies Examine New Topical For Onychomycosis

By Brian McCurdy, Senior Editor
Two phase III studies, recently published in the Journal of the American Academy of Dermatology, say a new topical triazole antifungal may be a viable alternative to oral treatments for onychomycosis.

   Researchers conducted two identical, multicenter, randomized, double-blind studies on a total of 1,655 patients with distal lateral subungual onychomycosis. Patients received either a vehicle or efinaconazole 10% (Valeant Pharmaceuticals), which they applied once a day for 48 weeks with four weeks of follow-up. The study authors note that mycological cure rates were “significantly higher” for patients treated with the topical agent. Treatment success rates in the first study ranged from 21.3 to 44.8 percent for efinaconazole patients in comparison to 5.6 to 16.8 percent for vehicle patients, according to the study. Researchers noted that treatment success rates in the second study ranged from 17.9 to 40.2 percent for efinaconazole patients in comparison to 7 to 15.4 percent for vehicle patients.

   “I don’t think the future for antifungals is in the oral market. I think it is topicals,” says study co-author Richard Pollak, DPM.

   Warren Joseph, DPM, believes efinaconazole holds promise as a new topical treatment for onychomycosis. As he notes, to date, the Food and Drug Administration (FDA) has only approved one topical, ciclopirox lacquer (Penlac, Sanofi-Aventis), for onychomycosis and “most people were disappointed with its efficacy.” He elaborates that the FDA approved “complete cure” (defined as negative mycology and 0 percent residual involvement) rates for that drug were in the 5 to 8 percent range.

   Dr. Pollak says efinaconazole is more effective than other topical treatments. He also notes that while efinaconazole is more effective than ciclopirox and is nearly as effective or comparable to oral itraconazole (Sporanox, Janssen Pharmaceuticals), it is not as effective as the “gold standard” oral terbinafine (Lamisil, Novartis).

   Dr. Joseph opines that there is still room for more drugs and studies in topical therapy of onychomycosis. He points out that at least two more drugs are currently in or recently completed Phase III trials.

   “We will be seeing a major upstart in interest in this disease state in the very near future,” says Dr. Joseph, a Fellow of the Infectious Diseases Society of America and a consultant to Valeant Pharmaceuticals.

   However, there is still work to be done and Dr. Joseph says research needs to focus on proving the efficacy of the over-the-counter products podiatrists are selling to patients out of their offices. He says research must also determine the optimum dosing time, noting that shorter durations for topicals would improve patient adherence.

   Dr. Pollak cites the rise of generic terbinafine as why it may not be worthwhile to market a new oral for onychomycosis. When terbinafine was a brand name, he says there was a barrier to treatment since not all insurance companies covered it. However, now patients can buy a one-month supply of terbinafine in retail stores for $4.

   “The cost of treatment of fungal toenails systemically is not a barrier to anybody,” says Dr. Pollak, who is in private practice in San Antonio, Texas.

   Editor’s note: For a related article, see the Online Case Study “Could Efinaconazole 10% Have An Impact For Onychomycosis?” at http://tinyurl.com/artray3 .

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