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XACIATO™ (clindamycin phosphate vaginal gel, 2%)

XACIATOTM (clindamycin phosphate vaginal gel, 2%) as a Treatment for Bacterial Vaginosis

On December 7, 2021, Daré announced that the U.S. Food and Drug Administration (FDA) approved XACIATO [zah-she-AH-toe] (clindamycin phosphate vaginal gel, 2%) (formerly known as DARE-BV1) for the treatment of bacterial vaginosis in females 12 years of age and older.

  • Please click here for full Prescribing Information.
  • On March 31, 2022, Organon (NYSE: OGN), a global women’s healthcare company, and Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, announced they have entered into an agreement whereby Organon will license global rights to XACIATOTM (clindamycin phosphate vaginal gel, 2%).

ABOUT BACTERIAL VAGINOSIS

Bacterial vaginosis is the most common type of vaginal infection in women of reproductive age. In the U.S. alone, bacterial vaginosis is estimated to affect approximately 21 million women.1 While there are several orally and vaginally delivered therapeutic interventions indicated for the treatment of bacterial vaginosis, currently approved options in the U.S. have relatively insufficient clinical cure rates, require sequential daily administrations or can be otherwise inconvenient for women to use.

In addition to being most common type of vaginal infection in women of reproductive age with bothersome symptoms, bacterial vaginosis has been associated with certain increased health risks.2

  • Preterm birth – bacterial vaginosis is linked to premature deliveries, low birth weight babies
  • Sexually transmitted infections – bacterial vaginosis increases susceptibility to HIV, herpes simplex virus, chlamydia, gonorrhea
  • Post-surgical infection – bacterial vaginosis may increase risk of infection after gynecologic procedures
  • Pelvic inflammatory disease – bacterial vaginosis may cause PID, an infection that affects women’s reproductive organs and can increase the risk of infertility

Footnotes:

1 https://www.cdc.gov/std/bv/stats.htm2
2 https://www.mayoclinic.org/diseases-conditions/bacterial-vaginosis/symptoms-causes/syc-20352279