When it comes to contraception, women value convenience and efficacy. Most women would prefer a contraceptive method they don’t need to remember to take every day and that doesn’t require action at the time of intercourse. Additionally, survey data showed that nearly 85% of women would prefer a monthly option with a lower hormone dose than the oral birth control pill. We at Daré are working to offer women a contraceptive option with these features.
Ovaprene® is an investigational hormone-free monthly intravaginal contraceptive designed to be worn conveniently over multiple weeks (one menstrual cycle) and prevent pregnancy by releasing a locally acting, non-hormonal agent which impedes sperm motility, and physically blocking sperm from entering the cervical canal with its unique knitted polymer barrier. The novel combination of these complementary approaches has the potential to produce efficacy consistent with existing short-acting hormone birth control options (pills, patches, vaginal ring), without the use of hormones.
In a postcoital test (PCT) study, Ovaprene® successfully immobilized sperm and prevented their progression into the cervical canal. PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness. Based on the positive results of our PCT study, we submitted an Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). During the fourth quarter of 2022, we announced that the FDA approved our IDE application allowing us to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene®. The IDE approval reflects that the FDA determined we provided sufficient data to support the initiation and conduct of the planned pivotal study.
In July 2021, we announced that we entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene®. The agreement will allow us to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.
With the IDE approval, the FDA provided additional study design considerations that we believe will further position this pivotal study to collect safety and effectiveness data to support the submission of a Premarket Approval (PMA) application. Therefore, we are working with our collaborators at NICHD and Bayer to review and implement the FDA’s recommendations. We and NICHD held a clinical trial investigator meeting for the Ovaprene pivotal study in December 2022, and we are targeting mid-year 2023 for study recruitment initiation.
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 over a 12-month duration (13 menstrual cycles). If successful, we expect the pivotal study to support marketing approvals of Ovaprene® in the U.S. and other countries. If Ovaprene® is approved by the FDA, it could be the first monthly non-hormonal contraceptive option for women and a first-in-category therapy for women seeking a hormone-free, self-administered birth control method.
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