The Top Ten Innovations In Podiatry
Each year, podiatric physicians gain new tools to add to their armamentariums to treat a variety of lower extremity conditions. Accordingly, this author speaks to experts in the field about new surgical advances, emerging wound care modalities, promising antifungals and a new line of OTC orthoses.
This year’s innovations include a new extracellular matrix, more convenient negative pressure wound therapy (NPWT), advanced technology for ankle replacement, a cream to treat tinea pedis and the development of the first new topical treatment for onychomycosis in more than a decade. Without further ado, here is what our experts had to say.
Efinaconazole (Valeant Pharmaceuticals). In the last decade or so, the flow of new agents for onychomycosis has slowed to a trickle. However, efinaconazole is a new player in the game. Warren Joseph, DPM, notes that if the Food and Drug Administration (FDA) approves the agent, efinaconazole will be the first new topical treatment for onychomycosis to receive FDA approval since ciclopirox 8% lacquer (Penlac) almost 15 years ago.
“This will also, hopefully, usher in a new generation of potential topical therapies with a number of others currently in different phases of clinical trials, thus giving clinicians new choices on how to treat this difficult condition,” says Dr. Joseph, a Fellow of the Infectious Diseases Society of America and a consultant to Valeant.
As Richard Pollak, DPM, notes, efinaconazole is the first topical triazole antifungal for the treatment of distal lateral subungual onychomycosis. He cites high mycological cure rates in two studies, 55.2 percent and 53.4 percent respectively, calling the topical antifungal treatment “a viable alternative for the treatment of onychomycosis.”
Dr. Pollak, a principal investigator in one of the aforementioned studies, also notes the treatment had a success rate of 44.8 percent in one study and 40.2 percent in another study.
“This topical agent is two to three times more effective than Penlac (Sanofi Aventis) and it has mycological cure rates and complete cure rates that are comparable to oral Sporanox (Janssen Pharmaceuticals),” says Dr. Pollak, who is in private practice in San Antonio. “Since this a topical antifungal, it is not only safe but more efficacious than any currently available topical antifungals on the market.”
As Dr. Joseph elaborates, the complete cure rate of efinaconazole was in the low to mid-20 percent range, comparing favorably to the same endpoint in the oral antifungal trials of itraconazole (14 percent), terbinafine (38 percent) and significantly higher than the only other approved topical, Penlac (5.5 to 8.8 percent).
Given that many patients are concerned about drug-drug interactions with oral antifungals and the possible risk of liver dysfunction, Dr. Pollak says the topical nature of efinaconazole is advantageous. Both he and Dr. Joseph say questions remain on drug pricing and insurance, and Dr. Pollak questions whether health management organizations will cover the drug once it is marketed or if insurers will ask practitioners to first try less efficacious topicals simply due to price concerns.
Dr. Joseph notes that the topical would only be approved for “mild to moderate” cases of onychomycosis so there will likely be no data on some of the more severe cases that podiatrists frequently see.
Onmel (Merz Pharmaceuticals). For another antifungal option, physicians may want to try a new dosing regimen for oral itraconazole. Onmel offers once daily dosing of 200 mg of itraconazole, notes the manufacturer Merz Pharmaceuticals. The agent can treat onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes in patients who are not immunocompromised, according to the company.