TOL-463, a boric acid-based treatment that is enhanced with ethylenediaminetetra-acetic acid (EDTA), is effective and safe in treating bacterial vaginosis and vulvovaginal candidiasis, according to a study published in Clinical Infectious Diseases.
This single-blind, randomized, phase 2 study included 106 individuals, 53 of whom had bacterial vaginosis, 36 of who had vulvovaginal candidiasis, and 17 of whom had both. Researchers randomly assigned participants in a 1:1 ratio to 1 week of either TOL-463 vaginal insert or the same medication in a gel formulation. Bacterial vaginosis was cured in 59% (95% CI, 41%-75%) of participants using TOL-463 insert and in 50% (95% CI, 31%-69%) of those using the gel. In patients with vulvovaginal candidiasis, the cure rate with the TOL-463 insert was 92% (95% CI, 67%-99%) vs 81% (95% CI, 57%-93%) for patients who received treatment with the gel. The most common adverse event was a sensation of vulvovaginal burning, which occurred in 9.6% of users. Otherwise, both gel and insert formulations of the medication were well tolerated and led to no secondary vulvovaginal candidiasis.
At the third visit, mITT analysis revealed a 13% (95% CI, 4%-31%) and 30% (95% CI, 16%-48%) clinical cure rate among those with bacterial vaginosis using gel and insert, respectively. The vulvovaginal candidiasis group showed significantly higher clinical cure rates, with 81% (95% CI, 57%-93%) and 77% (95% CI, 50%-92%) in the gel and insert groups, respectively.
Among the participants in this study, the mean age was 31, and 69% were African American. Test of cure was administered between days 9 and 12, with safety assessments occurring both at test of cure and between days 21 and 30.
The study researchers concluded that “TOL-463 is effective and safe in the treatment of [bacterial vaginosis] and [vulvovaginal candidiasis], with the vaginal insert demonstrating a more efficacious profile for both conditions overall. The potential dual indication of TOL-463 likely represents a benefit in the management of infectious vaginitis as diagnosis of these infections is often imprecise. Phase 3 trials will further define the role of TOL-463 in a more representative gynecology population across a broader range of practice settings and patient types.”
Marrazzo JM, Dombrowski JC, Wierzbicki MR, et al. Safety and efficacy of a novel vaginal anti-infective, TOL-463, in the treatment of bacterial vaginosis and vulvovaginal candidiasis: a randomized, single-blind, phase 2, controlled trial [published online August 31, 2018]. Clin Infect Dis. doi: 10.1093/cid/ciy554