Daré Bioscience Announces IDE Approval for a Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Investigational Hormone-Free Monthly Intravaginal Contraceptive

Daré Bioscience, Inc. recently announced the US FDA approved an Investigational Device Exemption (IDE) application allowing Daré to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive. The IDE approval reflects that the FDA determined the company provided sufficient data to support the initiation and conduct of the study. The IDE submission included the results of the postcoital test (PCT) clinical study of Ovaprene, in which Ovaprene prevented essentially all sperm from entering the cervical canal across all women and all cycles evaluated. PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness.

“We are driven to bring forward innovative options that support women’s health and wellness, and we are motivated to accelerate the development and introduction of differentiated product candidates, like Ovaprene, which is both hormone-free and designed to be conveniently kept in place vaginally continuously over the weeks between menstruation,” said Sabrina Martucci Johnson, President & CEO of Daré Bioscience. “When it comes to contraception, many of the top-selling brands in the category are delivering both convenience and efficacy, suggesting that women and healthcare providers have a preference for contraceptive methods that are effective, that don’t need to be administered every day, and that don’t require action at the time of intercourse.”

In order for the planned study to serve as the primary clinical support for a future marketing approval or clearance, the FDA provided additional study design considerations with the IDE approval letter.

“The FDA communication confirms our alignment on a number of key aspects of the clinical study, including the adequacy of a 12-month (13 menstrual cycles) duration. The additional study design considerations provided by the FDA are considered by the FDA to be recommendations that do not need to be addressed in order for us to initiate and conduct this study. However, implementing the guidance that we received from the FDA will further position this pivotal study to collect safety and effectiveness data that will support the submission of a Premarket Approval (PMA) application. Therefore, we look forward to working with our collaborators at the NIH and at Bayer to review and implement the recommendations and we are targeting mid-year 2023 study recruitment initiation,” she continued.

The multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive device along with its safety and usability. If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the US and other countries.

In July 2021, Daré entered into a Cooperative Research and Development Agreement (CRADA) with the US Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), to collaborate on the pivotal Phase 3 study of Ovaprene. The agreement gives Daré access to the full contraceptive clinical trial expertise of the NICHD clinical trial network while also sharing the costs of the Phase 3 pivotal study with the NICHD. The NICHD will hold an Ovaprene clinical trial investigator meeting in December of this year.

In January 2020, Daré and Bayer announced an exclusive licensing agreement for US commercial rights to Ovaprene. Under the agreement, Daré received an upfront payment and access to Bayer’s extensive clinical and market capabilities while retaining control over Ovaprene’s development and regulatory approval process. Bayer received the right to obtain exclusive rights to commercialize the product in the US following completion of the pivotal clinical trial being undertaken by Daré. If Bayer, in its sole discretion, makes payment to Daré of $20 million, which Daré intends to apply to reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the US will become effective. Daré will also be entitled to receive commercial milestone payments potentially totaling $310 million, in addition to double digit tiered royalties on net sales.

If Ovaprene is approved by the FDA, it could be the first monthly non-hormonal contraceptive product for women and a first-in-category option for women seeking a hormone-free, self-administered and monthly birth control method.

Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.

Daré’s first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly contraceptive whose US commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. For more information, visit www.darebioscience.com.