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New Drugs for Treating Fungal Infections a Review of Recent Developments for Efficacious Treatment

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New Drugs for Treating Fungal Infections a Review of Recent Developments for Efficacious Treatment COVER FOCUS New Drugs for Treating Fungal Infections A review of recent developments for efficacious treatment. BY NEAL BHATIA, MD, FAAD, AND TED ROSEN, MD here have been many recent additions to the arma- mentarium—from new dosing protocols to new PRACTICAL POINTER drugs—for treating onychomycosis and other fungal infections. And there are other potential new thera- Tavaborole represents a new class of antifungals. piesT on the way. Here, we’ll review the latest research. Tavaborole inhibits an essential fungal enzyme, leucyl transfer RNA synthetase, or LeuRS, required for protein Luliconazole Cream 1%. In 2013, the FDA approved Luzu synthesis, which leads to termination of cell growth and (luliconazole, Valeant) Cream, 1% for the topical treatment of cell death, eliminating the fungal infection. interdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. It is the first topical azole antifungal Naftifine Gel 2%. Last year, the FDA approved Naftin (naf- agent approved to treat tinea cruris and tinea corporis with a tifine HCl, Merz North America) Gel 2% for the treatment of one-week, once-daily treatment regimen. All other approved interdigital-type tinea pedis. Naftin Gel 2% improves on the treatments require two weeks of treatment. Interdigital tinea current formulation of Naftin Gel 1% by delivering the efficacy pedis is approved with a two-week, once-daily treatment. of naftifine hydochloride with a once-daily application treat- In a Phase II study of luliconazole for the treatment of inter- ment regimen. In clinical studies, Naftin Gel 2% demonstrated digital tinea pedis, complete clearance was achieved in 26.8 continuous improvement in post-treatment efficacy rates for percent and 45.7 percent of subjects in the two-week and up to four weeks after treatment regimen had ended. four-week treatment groups at two weeks post-treatment, Efinaconazole. Although the FDA rejected Valeant respectively.1 The study found that the antifungal effect per- Pharmaceuticals’ New Drug Application for efinaconazole sisted several weeks post-treatment, resulting in increased rates for the treatment of onychomycosis in 2013, the questions of mycologic and clincal cure. Four weeks post-treatment com- raised by the FDA that precluded the approval pertained plete clearance rates were 53.7 percent and 62.9 percent for the only to Chemistry, Manufacturing and Controls areas of the two-week and four-week treatment groups, respectively. container closure apparatus. No efficacy or safety issues were When comparing in vitro and in vivo antidermatophyte raised by the FDA. Efinaconazole, a novel triazole antifungal activities, luliconazole exhibited strong antifungal activity agent, inhibits fungal lanosterol 14α-demethylase involved against Trichophyton spp—its minimum inhibitory con- in ergosterol biosynthesis at concentrations below minimum centration (MIC) was one to four times lower than that of inhibitory concentrations.3 lanoconazole or terbinafine.2 Seven-day topical therapy with Efinaconazole has been found to be 4.8 times more potent 0.5% solution luliconazole was shown to be more effective than itraconazole in inhibiting ergosterol biosynthesis in T. than lanoconazole or terbinafine (0.5%). Only luliconazole mentagrophytes and 7.3 times more potent than clotrima- achieved complete mycologic cure. zole in C. albicans. FEBRUARY 2014 PRACTICAL DERMATOLOGY 29 COVER FOCUS TABLE 1. TAVABOROLE MET ALL PRIMARY AND SECONDARY ENDPOINTS WITH HIGH Statistical SIGNIFICANCE (ALL P ≤0.001) Study 301 Study 302 (N = 594) (N = 601) (active / ehicle) (active / vehicle) Primary • Completely clear nail and 6.5% / 0.5% 9.1% / 1.5% Endpoint mycological cure (defined as at 52 wk negative culture and negative KOH) of target great toenail Secondary • Completely clear or almost clear 26.1% / 9.3% 27.5% / 14.6% Endpoints (≤10% clinical involvement) target at 52 wk great toenail • Mycological cure of target great 31.1%/7.2% 35.9% / 12.2% toenail • Completely clear or almost clear nail 15.3% / 1.5% 17.9% / 3.9% + mycological cure Other • Negative culture 87.0% / 47.9% 85.4% / 51.2% • Completely clear or almost 24.6% / 5.7% 25.3% / 9.3% In a multicenter, randomized, double-blind, vehicle-con- trolled Phase II study investigating the efficacy and safety efi- naconazole in distal lateral subungual onychomycosis (DLSO), 135 subjects were randomized in a 2:2:2:1 ratio to receive efinaconazole 10% solution (with or without semiocclusion), efinaconazole 5% solution, or vehicle, once daily for 36 weeks, with one four-week post-treatment follow-up. Efficacy assess- ments included complete cure, mycologic cure, clinical efficacy, and other At follow-up, complete cure was numerically higher in all active groups (16 percent to 26 percent) compared with vehicle (nine percent). Mycologic cure rates with efinaconazole 10% semiocclusion, efinaconazole 10%, and efinaconazole 5% were 83 percent, 87 percent, and 87 percent, respectively. Efinaconazole 10% (with or without semiocclusion) demon- strated significantly greater clinical efficacy and treatment effec- tiveness when compared with vehicle (P=.0088 and .0064; .0056 Figure 1 and .0085, respectively, for both efinaconazole 10% groups).4 It has also been shown that efinaconazole has a higher percentage meaningful results on all primary and secondary endpoints in of drug unbound to keratin resulting in greater cumulative nail both Phase III pivotal studies of tavaborole to treat onychomy- permeation compared to ciclopirox.5 cosis topically without concomitant debridement (Table 1). Tavaborole. Anacor Pharmaceuticals’ NDA for tavaborole, Ciclopirox is currently approved to treat for onychomycosis a novel boron-based molecule for the topical treatment of with concomitant nail debridement. onychomycosis, was accepted by the FDA in October 2013. Tavaborole represents a new class of antifungals. Tavaborole The Prescription Drug User Fee Act (PDUFA) V goal date is inhibits an essential fungal enzyme, leucyl transfer RNA syn- July 29, 2014. The company announced that in two Phase III thetase, or LeuRS required for protein synthesis, which leads to trials, tavaborole demonstrated better efficacy than ciclopirox termination of cell growth and cell death, eliminating the fungal lacquer, the only approved topical treatment for onychomy- infection. The inhibitory activity of tavaborole requires the cosis. Tavaborole achieved statistically significant and clinically presence of boron within the compound. Boron has an empty 30 PRACTICAL DERMATOLOGY FEBRUARY 2014 COVER FOCUS P-orbital and can form a new bond under specific conditions. complete cure of onychomycosis. Safety of itraconazole 200mg The new bond forms a tetrahedral structure. Exploitation of is comparable to two 100mg itraconazole capsules.6 n P-Orbital expands drug design possibilities Econazole 1% Foam. Econazole foam 1% (Ecoza) is an This article is based on part of presentation on new drugs antifungal for the treatment of interdigital tinea pedis. presented at the 2014 Winter Clinical Dermatology Conference, Econazole 1% Foam was found to be superior to vehicle which took place January 17-22, 2014 in Hawaii. foam in mycologic cure and treatment efficacy (Figure 1). Ketoconazole. Ketoconazole Gel 2% (Xolegel) has the Neal Bhatia, MD, FAAD is in private practice same side effect precautions as oral ketoconzole on the in San Diego, CA. Dr. Bhatia has affiliations with label, but it is doubtful that the side effects are the same. Affiliations with Bayer, Dusa, Ferndale, Galderma, The FDA limited the use of ketoconazole oral tablets last Genentech, Leo, Onset, PharmaDerm, Promius, year, warning that the oral tablets can cause severe liver inju- Quinnova, and Valeant Pharmaceuitcals. ries and adrenal gland problems and advising that it can lead Ted Rosen, MD is a Professor of Dermatology, to harmful drug interactions with other medications. The Chief of Dermatology Service at Michael E. DeBakey FDA approved label changes and added a new Medication Veterans Affairs Medical Center at Baylor College Guide to address these safety issues. In some markets, the of Medicine in Houston, TX. Dr. Rosen has affili- authors note, the Xolegel Brand is cheaper than generic. ations with Anacor, Galderma, Genentech, Merz, Itraconazole. Itraconazole (Onmel) 200mg-dose tablets use Pharmaderm, and Valeant Pharmaceuitcals. Metrex technology to offer a convenient dose with enhanced 1. Jarratt M, Jones T, Kempers S, et al. Luliconazole for the treatment of interdigital tinea pedis: a double blind vehiclecon- bioavailability. The 200mg dose has the same active drug and trolled study. Cutis 2013;91:203-210. the same warnings at the 100mg tablets. There is no A/B-rated 2. Niwano Y, et al Antimicrob Agents Chemother 1998;42(4):967-970. 3. Tatsumi Y, Nagashima M, Shibanushi T, Iwata A, Kangawa Y, Inui F, Jo Siu WJ, Pillai R, Nishiyama Y. Mechanism of generic substitute for Onmel. Studies of itraconazole 200mg action of efinaconazole, a novel triazole antifungal agent. Antimicrob Agents Chemother. 2013;57(5):2405-2409 found statistically significant efficacy across all endpoints com- 4. Tschen EH, Bucko AD, Oizumi N, H Kawabata, JT Olin, R Pillai. Efinaconazole solution in the treatment of toenail onycho- mycosis: a phase 2 multicenter, randomized, double-blind study. J Drugs Dermatol 2013;12(2):186-192. pared to vehicle at Week 52 (40 weeks after the end of 12-week 5. Unique properties of efinaconazole 10% solution, a new topical treatment for onychomycosis. Sugiura K et al American Academy of Dermatology 71st Annual Meeting Miami March 2013. treatment). It is also noninferior to itraconazole capsules on 6. ONMEL® (itraconazole) 200-mg Tablets Prescribing Information. Merz Pharmaceuticals, LLC. 2012; Rev 11/12..
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