FDA approves application for investigational hormone-free contraceptive

The Food & Drug Administration has approved an Investigational Device Exemption (IDE) application to allow the US company Daré to conduct an efficacy study of its hormone-free contraceptive.

Daré Bioscience, a clinical-stage biopharmaceutical company aiming to advance innovative products for women’s health, has designed Ovaprene to prevent pregnancy by releasing a locally acting, non-hormonal agent which impedes sperm motility, and physically blocking sperm from entering the cervical canal with a knitted polymer barrier.

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 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.”

“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,” explained Johnson.

“The additional study design considerations provided by the FDA are considered by the administration 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 will further position this pivotal study to collect safety and effectiveness data that will support the submission of a Premarket Approval (PMA) application.

“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.”

The 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 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 commercialise the product in the US following completion of the clinical trial being undertaken by Daré.

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.