Daré Bioscience's Intravaginal Ring Improves Vasomotor, Vaginal Symptoms Of Menopause

  • Daré Bioscience Inc DARE announced topline efficacy results from its Phase 1/2 trial of DARE-HRT1. 
  • DARE-HRT1 is a novel, investigational intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over 28 days as part of a hormone therapy (HT) regimen. 
  • HT treats vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause. 
  • DARE-HRT1 can potentially be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and progesterone hormone therapy in a convenient monthly format. 
  • Estradiol levels released from the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved statistically significant improvement in VMS and the genitourinary symptoms of menopause and vaginal pH and maturation index.
  • The study treatment was well tolerated. The topline PK data from the study will be available later in Q4 of 2022.
  • Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol, and progesterone, to utilize FDA's 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S.
  • Price Action: DARE shares are up 4.21% at $0.93 on the last check Monday.
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