Celeste Krewson

Pinkerton reflects on the breakthrough approval for the non-estrogen, non-hormonal daily oral drug earlier this year.

Fezolinetant Changes Menopause Management, with JoAnn Vensko Pinkerton, MD

Earlier this year, the US Food and Drug Administration (FDA) approved fezolinetant (Veozah) for the treatment of moderate to severe vasomotor symptoms associated with menopause. The indication granted to Astellas Pharma in May marked the first neurokinin 3 receptor antagonist to reach the market for managing menopausal hot flashes.

Reaction to the once-daily oral drug’s breakthrough approval among OB/GYN specialists was resonant of excitement for a novel mechanism of care to treat hot flashes—and relief for the market’s long-awaited expansion to include options like fezolinetant.

assistant editor Celeste Krewson for This Year in Medicine 2023, JoAnn Vensko Pinkerton, MD, professor of obstetrics and gynecology at the University of Virginia and a credential menopause specialist with The Menopause Society, discussed the impact of fezolinetant’s FDA approval on menopause treatment. Chief among Pinkerton’s takeaways were the non-estrogen, non-hormonal makeup of fezolinetant—as well as her own personal experiences in prescribing the therapy.

Fezolinetant and Krewson additionally review the pivotal data from the SKYLIGHT trial program supporting fezolinetant, as well as anticipation for long-term utility and rollout of the agent to real-world patients in 2023 and beyond.

Petronelli M. FDA approves fezolinetant for vasomotor symptoms. 

Published May 12, 2023. https://www.contemporaryobgyn.net/view/fda-approves-fezolinetant-for-vasomotor-symptoms

Petronelli M. 'It's about time,' fezolinetant approval and latest research showcased at annual meeting. 

Published online May 19, 2023. https://www.contemporaryobgyn.net/view/-it-s-about-time-fezolinetant-approval-and-latest-research-showcased-at-annual-meeting

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Editor's note: This article originally appeared on 

Norgestrel (Opill; HRA Pharma) gained approval as the first nonprescription daily oral contraceptive by the US Food and Drug Administration (FDA) for preventing pregnancy.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

There are 6.1 million pregnancies annually in the US, of which about 50% are unintended. Adverse outcomes of unintended pregnancies include negative maternal and perinatal outcomes, such as increased preterm birth risk and decreased odds of receiving early prenatal care.

Individuals seeking contraception will be able to access norgestrel without consulting a health care provider, reducing barriers to contraception access. This may reduce the prevalence of unintended pregnancies and associated adverse outcomes.

"Of all the developed nations in the world, the US has the 

," Michael Aziz MD, MPH, maternal-fetal medicine specialist and member of the State Liaison Network for the Society for 

. "That's only gone up with the current COVID-19 pandemic."

Still, before the pandemic, the dangers of pregnancy were rising, showing disproportionate disparities. 

 are much higher than those observed in Caucasians. In addition to this, pregnancy can bring about potentially fatal obstacles for those with chronic conditions.

In 1973, norgestrel received FDA approval for prescription use, highlighting its contraceptive efficacy. The manufacturer, HRA Pharma, later applied for norgestrel to become an over-the-counter method of contraception. This required proof of safety and efficacy when used by consumers without support from a healthcare professional.

Research on norgestrel showed a significant percentage of consumers were capable of comprehending information on the Drug Facts label. Proper use of norgestrel is safe and effective, indicating it can be used as an over-the-counter product.

Efficacy of norgestrel is achieved when the product is used at the same time once daily, with efficacy decreasing if patients use medications that interact with norgestrel. Common side effects include dizziness, headaches, nausea, irregular bleeding, abdominal pain, cramps or bloating, and increased appetite.

"Today's approval is a groundbreaking expansion for women's health in the US, and a significant milestone towards addressing a key unmet need for contraceptive access," Frederique Welgryn, Perrigo Global Vice President for Women's Health said in a 

. "Perrigo is committed to making Opill, which is now the most effective method available OTC at preventing pregnancy, accessible and affordable to women and people of all ages.”

Norgestrel is not effective as emergency contraception and should not be used in patients with breast cancer or breast cancer history. It also should not be used alongside other hormonal birth control products, and use should be discontinued if pregnancy has been confirmed.

HRA Pharma will determine the price and availability timeline of norgestrel. Consumers will be able to purchase the product at convenience stores, grocery stores, drug stores, and online.

FDA approves firstnonprescription daily oral contraceptive. July 13, 2023. Accessed July 13, 2023. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

Grossi G. Michael Aziz, MD: Abortion Reduces Risk of Death. HCPLive. June 24, 2022. https://www.hcplive.com/view/michael-aziz-md-abortion-reduces-risk-of-death

Grossi G. Maternal Mortality Rates Highlight Alarming Inequities by State, Race/Ethnicity. HCPLive. July 3, 2023. https://www.hcplive.com/view/maternal-mortality-rates-alarming-inequities-state-race-ethnicity

Perrigo Announces U.S. FDA Approval for Opill® OTC Daily Oral Contraceptive. News Release. July 13, 2023. https://investor.perrigo.com/2023-07-13-Perrigo-Announces-U-S-FDA-Approval-for-Opill-R-OTC-Daily-Oral-Contraceptive

Articles

Individuals seeking contraception will be able to access norgestrel without consulting a health care provider, reducing barriers to contraception access.