Efficacy and safety of fosravuconazole L-lysine ethanolate, a novel oral triazole antifungal agent, for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study.

The Journal of Dermatology
Shinichi WatanabeAkihiro Okubo

Abstract

Fosravuconazole L-lysine ethanolate (F-RVCZ) is a prodrug of ravuconazole, a novel triazole antifungal agent, exerting broad and potent antifungal activity. The efficacy and safety of F-RVCZ, compared with a placebo, were investigated in a multicenter, double-blind, randomized study of Japanese onychomycosis patients with 25% or more clinical involvement of the target toenail. Subjects (n = 153) were randomly assigned to receive F-RVCZ (100 mg RVCZ, n = 101) or placebo (n = 52) p.o. once daily for 12 weeks. The primary end-point was the rate of complete cure (clinical cure [0% clinical involvement of the target toenail] plus mycological cure [negative potassium hydroxide examination]) at week 48 (36-week post-treatment visit). Secondary end-points were changes over time in the efficacy and mycological effect of F-RVCZ. Safety was also evaluated. The complete cure rate at week 48 was significantly higher with F-RVCZ (59.4%, 60/101) than the placebo (5.8%, 3/52) in the full analysis set (P < 0.001). The mycological cure rate at week 48 was also significantly higher with F-RVCZ (82.0%, 73/89) than the placebo (20.0%, 10/50, P < 0.001). Regarding safety, adverse events were observed in 83.2% (84/101) and 80.8% (42/52), and adverse ...Continue Reading

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Citations

Jan 29, 2019·Expert Opinion on Pharmacotherapy·Shari R Lipner
Jul 26, 2019·The Journal of Dermatology·Hiromitsu NoguchiHironobu Ihn
Jul 26, 2019·Medical Mycology·M R DavisG R Thompson
Nov 19, 2019·Recent Patents on Inflammation & Allergy Drug Discovery·Alexander K C LeungAlex H C Wong
Apr 3, 2020·Journal of the European Academy of Dermatology and Venereology : JEADV·Aditya K GuptaBianca Maria Piraccini
May 20, 2020·Antimicrobial Agents and Chemotherapy·Yara Almeida MachadoLívia de Figueiredo Diniz
Sep 27, 2020·The Journal of Dermatology·Takashi MochizukiUNKNOWN Guidelines Committee of the Japanese Dermatological Association
Jul 13, 2019·F1000Research·Aditya K Gupta, Nadia Stec
Oct 28, 2019·Expert Opinion on Emerging Drugs·Aditya K Gupta, Nadia Stec
Oct 26, 2020·The Journal of Dermatology·Hiromitsu NoguchiHironobu Ihn
Apr 17, 2021·The Journal of Dermatology·Ayaka MiyataYasushi Suga
Mar 24, 2021·Mycopathologia·Harunari ShimoyamaYoshihiro Kuwano
Apr 28, 2020·Journal of Medicinal Chemistry·Andrew C FlickChristopher J O'Donnell

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