By now, some of you might of heard of a new topical antifungal that may be coming. (or is coming). What makes it new?
- It has broad spectrum coverage. It is supposed to be good in the fight against not only dermatophytes, but Candida and molds as well (Aspergillus, Fusarium, etc.)
- It shows weak keratin binding which is important in that this gives the drug better nail penetration.
- It does not require debridement to work.
- it is not sticky like a lacquer. [Yes, many comparisons are made to Penlac.]
- it is supposed to be a superior topical antifungal agent to Penlac.

Truthfully, I never thought Penlac was impressive. Its own package insert boasted a success rate of something like 8% if my memeory serves me right.

This topical almost doubles the complete cure rates of Penlac.
Is the Podiatry World ready for this Topical?

Some thoughts to ponder: In the world of insurance company low reimbursements, and lack of a good topical antifungal therapy podiatry has found favor in office dispensing.....hence, I wonder if podiatry would want to embrace a presciption drug that would take money out of their pockets?
(a whole ethical question in and of itself).

Where could it help? Well, there are many docs using laser treatments now. Do these lasers work as well as some claim? possibly....though the evidence based medicine seems to be lacking.

Whenever, I ask for updates from colleagues on PM NEWS, I always get responses with protocols of people using oral terbinafine.

Here, perhaps, docs will convert to Efinaconazole 10% solution.

I find the name of this drug a bit curious...."Efinaconazole".....almost as if the people at Penlac are cursing out the conazole drug.....not that they care, their drug has been generic for a while....

I still wonder how Penlac ever got FDA approval....8% seems like a ridiculously low number.....I bet Vicks Vapor rub, Fresh Garlic and all those other treatments patients come in with amount to about an 8% succcess rate....
  • Comments (2)
  • Agree.

    Agree.

    Agree.

    Even the study of a few years ago showed that the majority of podiatrists believed that only oral antifungals had a chance of curing onychomycosis YET that same majority DID NOT PRESCRIBE THEM! Instead they turned to the nail nipper. Arrgghhhh! How frustrating. (Novartis funded that study but I do not believe that that fact negates its impact.)

    I believe that it is largely because there was a time, not so long ago, that we went to podiatry schools and not so much podiatric medical schools, with classes integrated with DOs or MDs or at the least, taught on par with those medical students.

    I see things changing. My students are just as likely, if not more, to feel comfortable picking up a prescription pad as they are a nail nipper. I hope that we are finally getting there. They spend two years learning about pharmaceuticals, their interactions, their side effects. I probably spent two months, at best, in an isolated, stand-alone "Pharmacology" course.

  • There is nothing topical that has been created that works anything near to the efficacy of oral antifungal therapy. The only things that drive the topical market is 1) Fear 2) Fear 3) Fear 4) Failure by podiatrists to look for data 5) Failure by podiatrists to ASK for data.

    First, the low published cure rates for any antifungal, topical or oral is simply a function if the FDA accepted definition of cure. Simply put, clinical and mycological cure must be present to call it a cure. However, most clinicans agree that in the case of Lamisil for example, the clinical response is around 80%. But when combined with mycology data, the "cure" rate falls to about 40%.

    Long before the office dispensing explosion (when there was no economic variable), podiatrists prescribed Penlac over Lamisil in some areas of the country by 800 to 1!!!!! This is not only outrageous, but clinically indefensible. The entire marketing strategy of PenLac was centered around SAFETY and capitalized on the fear of podiatrists and guess what? Saftey always beats efficacy in podiatry...and data is a secondary issue (some noted experts disagree with me on this). Even if you accuse me of trivializing the potential side effects of Lamisil, there was still no justification for it being considered in any way as a lateral product to PenLac, or any topical. In my opinion, and I have stated it publicly, (see recent Podiatry Today monograph on Efinaconazole) we have not informed our patients of the superiority of oral antifungal therapy when they are ready to make a therapeutic choice. At some derm meetings I have been to, the scuttle about Efinaconazole is that it has shown in trials some impressive advantage over existing topicals. Still, good results require motivated patients with documented laboratory confirmed onychomycosis who are willing to apply the agent daily for a minimum of a year. And of course, ten toenail total dystrophic onychomycosis is different than the patient who has mild disease limited to the distal medial corner of a nail, which in my opinion should be treated with a topical agent.

    Podiatrists all over the country however, attest at every major meeting that indeed the OTC topicals they are using in their offices are working very well for their onychomycosis patients. But for some reason not one of them puts together a series of even ten or fifteen patients with pre-treatment photos and treatment or post treatment photos.  I myself have many patients who speak of office-dispensed products they have bought at doctors offices that worked very well for them but their enthusiasm wanes and when they stop applying the product, the infection recurs. A pitifully small amount of them recived any information about skin maintenance, shoe sanitization, what the contribution of other family members with the infection may be, etc. These variables are very important if any definitive opinions on efficacy of any products are to be made.

    It may be very possible that the frequency of onychomycosis in our practices has jaded us into a bit of complacency so that we don't invest the time in explaining the nature and course of the disease, that it is invariably chronic, and that life-long maintenance is probably necessary. The manufacturers of products that understand this would be wise to incorporate these facts into their marketing, instead of telling the podiatrist that "you don't have to get blood tests" or "no worries about the liver."

    Disclosure: I hold or have held and/or participated in advisory positions with Valeant, Anacor, Bako Integrated Physician Solutions, Tetra Corporation, Novartis, and Janssen,