Daré Bioscience's One-Time Bacterial Vaginosis Treatment Scores FDA Approval

  • The FDA has approved Daré Bioscience Inc DARE Xaciato (DARE-BV1) to treat bacterial vaginosis. 
  • Xaciato is a thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a one-time vaginally-administered treatment for bacterial vaginosis.
  • The FDA accepted the application in August, based on results from the DARE-BVFREE study.
  • The study met its primary endpoint, demonstrating that as a primary therapeutic intervention, a single vaginal dose of DARE-BV1 was statistically superior to placebo at Day 21-30 (70% compared to 36% of subjects clinically cured). 
  • Additionally, DARE-BV1 demonstrated clinical cure rates of 77% at Day 21-30 and 81% at Day 7-14 in the per-protocol population, compared to 43% and 30% for placebo cream, respectively. 
  • See here Benzinga's Full FDA Calendar.
  • Price Action: DARE shares are increased 10.7% at $2.13 before the trading was halted during the market trading session on the last check Tuesday.
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