‘Amazing’: Oteseconazole prevents recurrent vulvovaginal candidiasis for 2 years
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Oteseconazole effectively treated recurrent vulvovaginal candidiasis and prevented acute episodes through 96 weeks, according to data presented at the Infectious Diseases Society for Obstetrics and Gynecology Annual Meeting.
Notably, oteseconazole (Mycovia Pharmaceuticals) was only administered through week 12.
“The take home message is that the drug is highly effective in preventing recurrences for well over a year,” Jack D. Sobel, MD, distinguished professor and former dean at the Wayne State University School of Medicine, told Healio.
“In fact, the results were statistically significant at 2 years,” Sobel, who credits the drug’s effectiveness to its long half-life, continued. “This is amazing.”
Sobel and colleagues conducted follow-up with 89 American participants with recurrent vulvovaginal candidiasis (RVVC) from the global, double-blinded phase 3 VIOLET trials.
In the VIOLET trials, all participants took fluconazole for 2 weeks and were then randomly assigned to oteseconazole or placebo for 12 weeks. They participated in follow-ups through week 48. For the present study, Sobel and colleagues contacted participants every 6 weeks to determine whether there were RVVC episodes from week 48 through week 96.
In total, 60 out of 71 (85%) of participants randomly assigned to oteseconazole and 13 of 18 (72%) who were randomly assigned to placebo followed up through week 96.
Compared with the placebo group, the oteseconazole group had a significantly lower incidence rate of acute VVC between 48 and 96 weeks (21% vs. 5%; P = .007) and from randomization through week 96 (73% vs. 15%; P < .001). The oteseconazole group also had a significantly longer time to recurrence (HR = 0.11; P < .001). On average, the oteseconazole group reached 92 weeks without recurrence.
The FDA approved oteseconazole in April for use in permanently infertile and postmenopausal women with RVVC. Moving forward, Sobel expressed interest in conducting research to prove the drug’s safety in other populations, such as in pregnant women.
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Sobel JD, et al. Abstract 45. Presented at: Infectious Diseases Society for Obstetrics and Gynecology Annual Meeting; Aug. 4-6, 2022; Boston.
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