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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 has the Potential to be the First FDA-Approved Monthly, Self-Administered, Hormone-Free Contraceptive Product SAN DIEGO, Oct. 10, 2022 (GLOBE
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Ovaprene has the Potential to be the First FDA-Approved Monthly, Self-Administered, Hormone-Free Contraceptive Product\nSAN DIEGO, Oct. 10, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food & Drug Administration (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,” Ms. Johnson continued, “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 guidanc...