Experimental drug shows therapeutic potential in acute vulvovaginal candidiasis
The oral antifungal drug VT-1161 (oteseconazole) is safe and effective in the treatment of women with acute vulvovaginal candidiasis (VVC), according to the results of a phase II study.
A total of 55 women presenting with an acute episode of VVC were randomized to receive a 3-day course of VT-1161 at 300 mg once daily (q.d.), 600 mg q.d., or 600 mg twice daily (b.i.d.), or a single dose of fluconazole 150 mg (currently FDA-approved dose to treat acute VVC). Researchers followed all patients for 6 months.
In the per-protocol population, more patients given oteseconazole 300 mg q.d. (75.0 percent), 600 mg q.d. (85.7 percent), and 600 mg b.i.d. (78.6 percent) vs fluconazole (62.5 percent) achieved the primary endpoint of therapeutic (clinical and mycological) cure at day 28. However, the differences across all treatment groups were not significant.
None of the patients on oteseconazole showed evidence of mycological recurrence at 3 and 6 months, whereas 28.5 percent and 46.1 percent of those on fluconazole did, respectively.
Oteseconazole was well tolerated. A total of 40 treatment-emergent adverse events (TEAEs) occurred across the investigational treatment groups and 22 in the fluconazole group. The most common TEAEs were in the infections and infestations system organ class, including nasopharyngitis, urinary tract infection, and bacterial vaginitis. There were no serious adverse events or discontinuations due to TEAEs documented.