Efinaconazole: First global approval

Drugs

Volumn 73, Issue 17, 2013, Pages 1977-1983

  Patel, Trina ^a   Dhillon, Sohita ^b  

^a Adis R and D Insight   (New Zealand)

^b ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

EFINACONAZOLE;

ANTIFUNGAL ACTIVITY; ARTICLE; DRUG APPROVAL; DRUG MECHANISM; DRUG SAFETY; HUMAN; MAXIMUM PLASMA CONCENTRATION; ONYCHOMYCOSIS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); TOENAIL ONYCHOMYCOSIS; UNSPECIFIED SIDE EFFECT;

ADMINISTRATION, TOPICAL; ANIMALS; ANTIFUNGAL AGENTS; DRUG APPROVAL; HUMANS; ONYCHOMYCOSIS; PHARMACEUTICAL SOLUTIONS; TRIAZOLES;

EID: 84892607399     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-013-0152-x     Document Type: Article

References (25)

1. Alley MR, Baker SJ, Beutner KR, et al. Recent progress on the topical therapy of onychomycosis. Expert Opin Investig Drugs. 2007;16(2):157-67.
2. Tchernev G, Penev PK, Nenoff P, et al. Onychomycosis: modern diagnostic and treatment approaches. Wien Med Wochenschr. 2013;163(1-2):1-12.
3. Gupta AK, Paquet M, Simpson FC. Therapies for the treatment of onychomycosis. Clin Dermatol. 2013;31(5):544-54.
4. Jarratt M, Siu WJ, Yamakawa E, et al. Safety and pharmacokinetics of efinaconazole 10 % solution in healthy volunteers and patients with severe onychomycosis. J Drugs Dermatol. 2013;12(9):1010-6.
5. Rich P. Topical treatment of onychomycosis with efinaconazole solution 10 %. Cutis. 2013;91(6):305-7.
6. Valeant Pharmaceuticals International Inc. Valeant Pharmaceuticals announces approval of Jublia for the treatment of onychomycosis in Canada [media release]. 3 Oct 2013. http://ir.valeant. com/investor-relations/news-releases/ news-release-details/2013/Valeant-Pharmaceuticals-Announces-Approval-Of-Jublia- For-The-Treatment-Of-Onychomycosis-In-Canada/default.aspx.
7. Valeant Pharmaceuticals International Inc. Valeant pharmaceuticals announces receipt of U.S. FDA complete response letter for efinaconazole [media release]. 28 May 2013. http://ir.valeant. com/investor-relations/news-releases/ news-release-details/2013/Valeant-Pharmaceuticals-Announces-Receipt-Of-US-FDA- Com-plete-Response-Letter-For-Efinaconazole.
8. Kaken Pharmaceutical Co. Ltd. R&D pipeline. 2013. http://www.kaken.co.jp/english/rd-pipeline.html. Accessed 22 Oct 2013.
9. Valeant Pharmaceuticals International Inc. Valeant pharmaceuticals provides efinconazole update [mediarelease]. 2 May 2013. http://ir. valeant.com/investor-relations/news-releases/news-release-details/2013/ Valeant-Pharmaceuticals-Provides-Efinconazole-Update/default.aspx.
10. Valeant Pharmaceuticals International Inc. Valeant pharmaceuticals announces award in Anacor dispute [media release]. 18 Oct 2013. http://ir.valeant.com/investor-relations/news-releases/news-release-details/ 2013/Valeant-Pharmaceuticals-Announces-Award-In-Anacor-Dispute/default.aspx.
11. Valeant Pharmaceuticals Inc. Valeant Pharmaceuticals announces settlement agreement with Anacor [media release]. 28 Oct 2013. http://ir.valeant.com/ investor-relations/news-releases/news-release-details/2013/Valeant- Pharmaceuticals-Announces-Settlement-Agreement-With-Anacor/default.aspx.
12. Kaken P. Kaken pharmaceutical to license its antifungal compound KP-103 to Dow Pharmaceutical Sciences [media release]. 11 May 2006. http://www.japancorp.net/article.asp?Art-ID=12471.
13. Valeant Pharmaceuticals International Inc. Valeant Pharmaceuticals completes acquisition of Dow Pharmaceutical Sciences Inc [media release]. 2 Jan 2009. http://ir.valeant.com/investor-relations/news-releases/news-release- details/2009/Valeant-Pharmaceuticals-Completes-Acquisition-of-Dow- Pharmaceutical-Sciences-Inc/default.aspx.
14. Tatsumi Y, Nagashima M, Shibanushi T, et al. Mechanism of action of efinaconazole, a novel triazole antifungal agent. Anti-microb Agents Chemother. 2013;57(5):2405-9.
15. Bhatt V, Sarpotdar P, Pillai R, et al. Development of an optimal formulation for efinaconazole a novel antifungal agent for the treatment of onychomycosis by topical application [abstract no. P6541]. J Am Acad Dermatol. 2013;68(4 Suppl 1):AB104.
16. Tatsumi Y, Yokoo M, Arika T. In vitro antifungal activity of KP-103, a novel triazole derivative, and its therapeutic efficacy against experimental plantar tinea pedis and cutaneous candidiasis in guinea pigs. Antimicrob Agents Chemother. 2001;45(5): 1493-9.
17. Tatsumi Y, Yokoo M, Senda H. Therapeutic efficacy of topically applied KP-103 against experimental tinea unguium in guinea pigs in comparison with amorolfine and terbinafine. Antimicrob Agents Chemother. 2002;46(12):3797-801.
18. Jo Siu WJ, Tatsumi Y, Senda H, et al. Comparison of in vitro antifungal activities of efinaconazole and currently available antifungal agents against a variety of pathogenic fungi associated with onychomycosis. Antimicrob Agents Chemother. 2013;57(4): 1610-6.
19. Sugiura K, Hosaka S, Sugimoto N, et al. Efinaconazole's nail penetration and fungicidal activity may contribute to its therapeutic efficacy as a topical treatment for onychomycosis [abstract no. 1151]. J Invest Dermatol. 2013;133(Suppl 1):S195.
20. Del Rosso JQ, Reece B, Smith K, et al. Efinaconazole 10 % solution: a new topical treatment for onychomycosis: contact sensitization and skin irritation potential. J Clin Aesthet Derma-tol. 2013;6(3):20-4.
21. Glynn M, Nejishima H, Sanada H, et al. Efinaconazole 10 % solution: nonclinical safety supports topical use in onychomy-cosis [abstract no. P6552]. J Am Acad Dermatol. 2013;68(4 Suppl 1):AB105.
22. Jo W, Glynn M, Minowa K, et al. Efinaconazole: developmental and reproductive toxicity potential [abstract no. P712]. Int J Toxicol. 2013;32(1):82-3.
23. Jo Siu W, Mutter L, Aoyama A, et al. In vitro CYP inhibition and induction assessments of efinaconazole coupled with low clinical systemic exposure suggest low DDI potential in topical onycho-mycosis [abstract no. 1140]. J Invest Dermatol. 2013;133 Suppl 1:S193.
24. Elewski BE, Rich P, Pollak R, et al. Efinaconazole 10 % solution in the treatment of toenail onychomycosis: two phase III multicenter, randomized, double-blind studies. J Am Acad Dermatol. 2013;68(4):600-8.
25. Tschen EH, Bucko AD, Oizumi N, et al. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013;12(2): 186-92.