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Wo 2010/010470 A2 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 28 January 2010 (28.01.2010) WO 2010/010470 A2 (51) International Patent Classification: (74) Agents: WEBER, Martin et al; Jones Day, Prinzregen- A61K 31/137 (2006.01) A61K 47/44 (2006.01) tenstrasse 11, 80538 Munchen (DE). A61K 9/107 (2006.01) A61K 9/00 (2006.01) (81) Designated States (unless otherwise indicated, for every A61K 47/24 (2006.01) kind of national protection available): AE, AG, AL, AM, (21) International Application Number: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, PCT/IB2009/006742 CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 23 July 2009 (23.07.2009) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (25) Filing Language: English ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (26) Publication Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, (30) Priority Data: TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. 61/083,1 15 23 July 2008 (23.07.2008) US (84) Designated States (unless otherwise indicated, for every 61/102,1 11 2 October 2008 (02.10.2008) US kind of regional protection available): ARIPO (BW, GH, 61/150,1 87 5 February 2009 (05.02.2009) US GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, 61/168,122 9 April 2009 (09.04.2009) US ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, (71) Applicant (for all designated States except US): TDT, TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, LTD [MTMT]; Palazzo Pietro Stiges, 90 Strait Street, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, Valleta (MT). MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, (72) Inventors; and ML, MR, NE, SN, TD, TG). (75) Inventors/Applicants (for US only): CEVC, Gregor [DE/DE]; Tassilostrasse 3, D-Gauting (DE). VIERL, Ul- Published: rich [DE/DE]; Milbertshofenerstrasse 52, D-80807 — without international search report and to be republished Munchen (DE). upon receipt of that report (Rule 48.2(g)) (54) Title: METHODS OF ADMINISTERING TOPICAL ANTIFUNGAL FORMULATIONS FOR THE TREATMENT OF FUNGAL INFECTIONS (57) Abstract: The present invention relates to topical antifungal formulations comprising one or more antifungal (e.g., terbinafme), a lipid and a surfactant, and uses thereof for the treatment of skin and nail fungal infections. METHODS OF ADMINISTERING TOPICAL ANTIFUNGAL FORMULATIONS FOR THE TREATMENT OF FUNGAL INFECTIONS PRIORITY [0001] This application claims the benefit of U.S. Provisional Application No. 61/083,1 15, filed July 23, 2008, U.S. Provisional Application No. 61/102,1 11, filed October 2, 2008, U.S. Provisional Application No. 61/150,187, filed February 5, 2009, and U.S. Provisional Application No. 61/162,122, filed April 9, 2009. The contents of each of these applications is hereby incorporated by reference herein their entirety. 1. FIELD OF INVENTION [0002] The present invention relates to topical formulations of an antifungal comprising one or more antifungals, a lipid and a surfactant, and uses thereof for the treatment of skin and nail fungal infections. 2. BACKGROUND [0003] Onychomycosis is a fungal infection of the fingernails and toenails that results in thickening, discoloration, splitting of the nails and lifting of the nails from the nail bed. The disease is caused by dermophytes and has a high incidence within the general population, especially among older individuals. Onychomycosis is most commonly caused by Trichophyton rubrum (T. rubruni), Trichophyton mentagrophytes (T mentagrophytes), and Epidermophyton floccusum (E.floccusum). Onychomycosis due to nondermatophytes is usually caused by Candida species, such as Candida albicans, and is more likely to cause invasive nail disease in fingernails than in toenails of immunocompetent individuals. [0004] Rates of onychomycosis vary with the population considered. A recent study of the general United States population revealed a prevalence of 2% to 3%, while a study reported in Finland reported a rate of 13% (Elewski et. ah, J. Am. Acad. Dermatol. 2000; 42(I)(Pt 1): 1-20., and Heikkila et. al, Br. J. Dermatol. 1995; 133(5): 699-703). Onychomycosis may affect up to about 15% of persons between the ages of 40 and 60 years (Kepka et. al. U.S. Patent Pub. No. 2006/0067898). [0005] Terbinafine is an antimycotic currently indicated as an oral therapy for the treatment of onychomycosis (Lamisil™, Novartis International AG, Basel, Switzerland). Other treatment options including chemical or surgical removal of the infected nail(s) can lead to nail bed shrinkage and dorsal dislocation of the nail bed. [0006] Citation of any reference in this section of the application is not an admission that the reference is prior art to the application. 3. SUMMARY OF THE INVENTION [0007] The present invention provides topical formulations of one or more antifungals, which may be used to treat fungal infections in a human subject. The topical antifungal formulations of the invention comprise one or more antifungals and one or more lipids and one or more surfactants in a pharmaceutically acceptable carrier. In certain embodiments, the antifungal is terbinafme, salts of terbinafme, or derivatives or analogs of terbinafme, either alone or in combination with one or more antifungals. In certain embodiments, the antifungal is abafungin, acrisorcin, albaconazole, albendazole, amorolfme, amphotericin B, anidulafungin, arasertaconazole, azithromycin, becliconazole, benzodithiazole, bifonazole, butoconazole, butenafine, calbistrin, caspofungin, N-chlorotaurine, chloroxine, chlorphenesin, ciclopirox, cioteronel, clotrimazole, croconazole, cytoporins, deoxymulundocandin, eberconazole, econazole, efungumab, fenticonazole, flavanoid glycosides, fluconazole, flucytosine, flutrimazole, fosfluconazole, genaconazole, gentian violet, griseofulvin, griseofulvin PEG, haloprogin, hydroxy itraconazole, isoconazole, itraconazole, ketoconazole, lanoconazole, letrazuril, liranaftate, luliconazole, micafungin, miconazole, mycophenolic acid, naftifine, natamycin, nitazoxanide, nitro-ethylene based antifungals, nystatin, omocanazole, oxiconazole, polyene macrolide, polyene macrolide, posaconazole, pramiconazole, quinolone analogs, rapamycin, ravuconazole, rilopirox, samidazole, sertaconazole, sitamaquine, sordaricin, squalestatin, squalene, a squalene epoxidase inhibitor, sulconazole, sultriecin, tafenoquine, terconazole, tioconazole, tolnaftate, voriconazole, or a compound of Formula I : or a single enantiomer, a mixture of enantiomers, or a mixture of diastereomers thereof; or a pharmaceutically acceptable solvate, hydrate, or salt thereof; where R is C1-12 alkyl, C1-12 acyl, or heteroaryl-C6-i4 aryl; X is halo; Y is N or CH; and Z is CH or O. In certain embodiments, the topical antifungal formulations of the invention comprise terbinafme, one or more phospholipids and one or more nonionic surfactants. In certain embodiments, the topical antifungal formulations of the invention comprise terbinafme and an additional antifungal, one or more phospholipids and one or more nonionic surfactants. In certain embodiments, the topical antifungal formulations provided herein comprise one of itraconazole, ketoconazole, posaconazole, saperconazole, SCH-50002, terconazole, butenafme, and griseofulvin; and hydrates, solvates, and salts thereof; one or more phospholipids, and one or more nonionic surfactants. In certain embodiments, the antifungal formulations provided herein comprise an antifungal agent that is from a class of antifungal agents that include, bur are not limited to, antimetabolites, macrolides, echinocadins, imidazoles, triazoles, benzylamines, griseofulvins, allylamines, polyenes, thiocarbamates, and halogenated phenol ethers. The disclosure relates to topical formulations, such as solutions, suspensions, gels, fluid gels, emulsions, emulsion gels, lotions, ointments, film forming solutions, creams, sprays and lacquers. [0008] In particular, the antifungal formulations of the invention may be used to treat or prevent onychomycosis in a human subject. The antifungal formulations of the invention may also be used to treat or prevent fungal infections of the skin including, but not limited to tinea corporis, tinea cruris, tinea pedis, pityriasis (tinea) versicolor. The antifungal formulations of the invention may also be used to treat fungal infections commonly caused by Trichophyton (e.g., T. rubru, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccusum (E.floccusum) and yeasts of the genus Candida (e.g., Candida albicans), as well as Malassezia furfur. [0009] The antifungal formulations of the invention facilitate the delivery of antifungal to the infected area in an amount sufficient to treat the fungal infection. In the case of onychomycosis, the formulation can be administered to the nail and/or the surrounding skin. The formulation may also be administered to the entire toe and/or finger tip. The formulation may preferably be administered to the distal phalanx of the finger or toe. In the case of skin infection, the formulation can be administered to the infected area of the skin. In one embodiment, the topical terbinafme formulation is applied to the surface of the nail (i.e., the nail plate)
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