Daré Bioscience Announces Publication in The Journal of The North American Menopause Society of Positive Efficacy Findings for the Treatment of Menopausal Symptoms from a Phase 1/2 Clinical Trial of DARE-HRT1 Intravaginal Rings - Seite 2

“More women are looking for options to manage their moderate-to-severe vasomotor symptoms that are commonly associated with menopause. We are encouraged by the findings from this study as we believe DARE-HRT1 has the ability to address a persistent unmet medical need,” said Andrea Thurman, MD, Medical Director for Daré Bioscience and lead author of the journal article. “In this study, preliminary VMS treatment efficacy was supported by significant decreases from baseline in all domains of the Menopause-Specific Quality of Life (MENQOL) questionnaire for both dosing groups (p<0.01), indicating improvement in the overall MENQOL score and in all MENQOL domains, and preliminary local GSM treatment efficacy was supported by significant improvement in vaginal cytology parameters for both dosing groups and improvement in bothersome vaginal symptoms commonly associated with GSM.”

“Data from this study support further development of DARE-HRT1 as a potential first-in-category product to offer bio-identical estradiol and bio-identical progesterone therapy in a convenient monthly, non-oral format, consistent with NAMS guidance for delivering both hormones, together,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We look forward to advancing DARE-HRT1 into a single Phase 3 pivotal clinical trial to support a new drug application for the treatment of moderate-to-severe VMS due to menopause in women with intact uteri.”

Hormone therapy is recommended as a first-line, effective treatment for the management of VMS and GSM among healthy postmenopausal women by the American College of Obstetricians and Gynecologists, the International Menopause Society, and NAMS. NAMS’ guidance on hormone therapy states that dosing estrogen and progestogen in combination may offer important benefits to women with an intact uterus, and NAMS observed that non-oral routes of administration may offer advantages over orally administered therapies because nonoral routes bypass the first-pass hepatic effect.

About Menopause

Menopause is defined as the final menstrual period and is typically confirmed after a woman has missed her period for 12 consecutive months. Most women experience menopause between ages 40 and 58.1 Over 45 million women in the U.S. are estimated to be approaching or in menopause, which results in a decrease in estrogen and other hormones.^1,2 Hot flashes, vaginal dryness and loss of bone density are frequently associated with menopause. Night sweats (hot flashes that occur during sleep) often cause sleep disturbance, and vaginal atrophy (the drying and thinning of vaginal tissues) can cause a feeling of vaginal tightness during sex along with pain, burning, or soreness.¹ Hence, management of menopausal symptoms can impact quality of life, productivity and health. NAMS believes that hormone therapy is the most effective treatment for VMS and GSM and observes that a non-oral route may offer potential advantages over oral routes of administration.²