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10 Jan, 2024
JERSEY CITY, N.J.-- Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV). BV results from an overgrowth of certain bacteria, which upsets the balance of the natural vaginal microbiome (environment) and can lead to symptoms of odor and discharge. BV has also been shown to disproportionately affect non-Hispanic Black and Mexican American women.
In addition to the physical symptoms, BV can also impact a woman’s emotional wellbeing. In fact, a 2017 survey among 304 women diagnosed with BV2 found that 79% avoided intimacy with their partner2 and 68% felt self-conscious because of their condition. Most women with symptoms of BV require treatment. Women with recurrent BV have reported frustration with recurrence after initial treatment, with 58% of them experiencing recurrent infection within 12 months.
XACIATO, pronounced zah-she-AH-toe, is a colorless single-dose vaginal gel that can be applied at any time of day and is formulated with the goal of limiting leakage and increasing vaginal retention time (time spent in place).4 As demonstrated by an in vitro study using clindamycin HCl, the gel increases viscosity (thickness and stickiness) at body temperature and gradually releases clindamycin, over time.
“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 contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
“BV is the most common form of vaginitis, disrupting the lives of approximately 21 million women.1,5 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 Bioscience completed an agreement whereby Organon will license global rights to XACIATO.
Information about XACIATO, and the eVoucher instant savings coupon for eligible patients, can be found at XACIATO.com.
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