Organon, a global healthcare company focusing on women’s health, announced US-wide availability of XACIATO (clindamycin phosphate) vaginal gel 2% by prescription for the treatment of bacterial vaginosis (BV) in females aged 12 and older. BV, a condition resulting from an overgrowth of certain bacteria, disrupts the natural vaginal microbiome, leading to symptoms like odor and discharge. It affects approximately 21 million women in the United States and is known to disproportionately impact non-Hispanic Black and Latin American women.
BV not only causes physical symptoms but also significantly affects emotional well-being. Many women with BV avoid intimacy and feel self-conscious due to their condition. Furthermore, women with recurrent BV often experience frustration with recurrence after initial treatment, with 58% facing recurrent infection within 12 months.
“As a company focused on women’s health, we make it a priority to listen to women and their providers, so that we understand their needs and put forward innovative solutions,” said Juan Camilo Arjona Ferreira, M.D., Head of Research & Development and Chief Medical Officer at Organon. “What drew us to XACIATO is that it was formulated with specific needs in mind and studied in a patient population that was representative of women with BV.”
XACIATO is a single-dose vaginal gel designed to be applied at any time of day, formulated to minimize leakage and increase vaginal retention time. The gel, which becomes more viscous at body temperature, gradually releases clindamycin over time.
“BV is the most common form of vaginitis, disrupting the lives of approximately 21 million women. For these women, it’s important to consider her individual treatment needs, such as route of administration, cost, adverse events, dosing and duration of treatment,” said Erica Montes, M.D., Board-Certified Obstetrician and Gynecologist and a Fellow of the American College of OB/GYN. “The availability of XACIATO is important as it’s one dose for women experiencing BV and it can be taken at any time of day.”
In 2022, Organon and Daré Biosciences completed an agreement whereby Organon will license global rights to XACIATO.
