On October 10, Daré Bioscience announced that the FDA granted an Investigational Device Exemption (IDE) application allowing it to conduct a pivotal Phase III clinical study of Ovaprene, a non-hormonal contraceptive product. In addition, Daré anticipates that, if the study is successful, the results will serve as supporting material for Ovaprene’s marketing applications in the U.S. and other countries.
IDE is only for clinical medical devices, and aims to allow medical devices under development to be exempted from various supervisions for device products for marketing purposes, and to allow manufacturers to collect safety and efficacy through clinical trials in a simpler way. information materials.
Daré Bioscience Announces IDE Approval for a Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene®, an Investigational Hormone-Free Monthly Intravaginal Contraceptive
Ovaprene is an effective, hormone-free, once-monthly, intravaginal contraceptive product that does not require use during intercourse that blocks sperm motility by releasing a locally acting, non-hormonal component (ferrous gluconate) , and form a knitted polymer barrier to prevent sperm from entering the cervical canal, thereby achieving a contraceptive effect.
Daré’s IDE filing includes results from a clinical study of Ovaprene’s postcoital test (PCT, a surrogate measure of contraceptive effectiveness). In the study, Ovaprene prevented sperm from entering the cervical canal in essentially all groups of women and in all menstrual cycles.
The approved study is a multicenter, single-arm, uncontrolled, pivotal Phase III contraceptive study that will evaluate the efficacy, safety and usability of Ovaprene as a contraceptive device. At the same time, in order for this Phase III study to be the primary clinical support material for future Ovaprene applications for marketing approval or licensing, the FDA provided additional study design considerations in the IDE approval letter.
In this regard, Daré President and CEO Sabrina Martucci Johnson said: “Communications with the FDA confirmed our consistency in many key aspects of our clinical studies, including the adequacy of the 12-month (13 menstrual cycle) time frame. FDA stated that the additional study design considerations it provided were not necessary to enable us to initiate and conduct this study. However, implementing the recommendations provided by the FDA could collect additional safety and efficacy data to further help this pivotal study become a submission Supporting materials for premarket approval (PMA) applications. We therefore look forward to reviewing and implementing these recommendations with our collaborators, the National Institutes of Health (NIH) and Bayer, and we aim to initiate this study in mid-2023 patient recruitment.”
In July 2021, Daré entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human Services to collaborate with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD, an affiliate of NIH) on Ovaprene’s pivotal Phase III study. The agreement gives Daré access to the NICHD Clinical Trials Network’s full clinical trial expertise on contraception, while also sharing research costs with NICHD. The NICHD will hold an Ovaprene clinical trial investigator meeting in December this year.
In January 2020, Daré and Bayer entered into an exclusive license agreement granting them commercialization rights to Ovaprene. Under the agreement, Bayer will pay Daré $20 million after Daré completes the pivotal clinical trial. In addition, Daré will be entitled to commercial milestone payments that may total $310 million in addition to double-digit tiered royalties on net sales.
If approved by the FDA, Ovaprene would be the first once-monthly non-hormonal contraceptive product for women and the preferred option for women seeking a hormone-free, self-medicating and monthly method of contraception.