OAKLAND, Calif. – July 1, 2020 – Cadence Health, a mission-driven organization focused on women’s health OTC products, today announced the successful completion of four pivotal studies for Zena, the company’s combination oral birth control pill under investigation for Rx to OTC switch. These large quantitative studies were completed in preparation for the Actual Use Trial, which plans to enroll approximately 1,800 women who would use Zena for six months.
“We have completed 25 studies in approximately 1,900 women across the country to ensure that women understand and use Zena appropriately,” said Nap Hosang, M.D., Co-CEO and Chief Medical Officer of Cadence Health. “Our successful completion of these studies indicates that women understand both the label and consumer information booklet, and accurately decide for themselves whether this product is right for them. We look forward to initiating our final Actual Use Trial in 2021.”
Cadence has conducted twenty five studies in the course of developing information for consumers to determine whether females of child-bearing age can correctly understand and follow instructions about Zena without the assistance of healthcare professionals. These studies assessed the efficacy of the drug facts label on the outside of the box and the consumer information booklet inside the box and included a wide age distribution as well as people with low health literacy, as required by the FDA. These included several studies in high-risk populations who should not take a combined oral birth control pill, specifically women with a history of breast cancer and women who smoke cigarettes and are over 35 years of age.
“With the completion of the label comprehension and targeted self-selection studies, Cadence achieved a significant milestone on our path to bring oral birth control over the counter, empowering women to decide what works for their reproductive health,” commented Samantha Miller, Co-CEO of Cadence Health. “Importantly, we will ensure that Zena is accessible and affordable for all populations including those who are underserved today.”
We have a bold vision to bring the first combination birth control pill to anyone who wants it. It’s called Zena. Zena is on-path to be the first combination birth control pill available, affordable and accessible to women throughout the US (and beyond) without a prescription.
Zena's formula has been proven safe and effective when used as prescribed, however, following standard processes, the Food and Drug Administration requires extensive testing of OTC labeling before approving it for sale over-the-counter. Our experts are working diligently with the FDA towards approval for Zena.
About Cadence Health
Cadence Health is knocking down the obstacles between women and the reproductive health options they want – starting with our effort to move the Pill OTC. We’re making safe, affordable options available to all women, without a prescription. Based in Oakland, California, Cadence is founded, led, and supported by a diverse team of internationally renowned reproductive health experts, world-class entrepreneurs, and champions of women. A public benefits company, Cadence is committed to transforming reproductive health for all women everywhere.