FDA Approves Femlyv as First Dissolvable Oral Contraceptive

The US Food and Drug Administration (FDA) has given the green light to Femlyv, a combination oral contraceptive containing norethindrone acetate and ethinyl estradiol.

Femlyv is the first orally dissolvable tablet for preventing pregnancy.

Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy.

The tablet consists of two hormones: norethindrone acetate, a type of progestin, and ethinyl estradiol, a synthetic form of estrogen. Together, these hormones work to prevent ovulation, alter the uterine lining and thicken cervical mucus, making it more difficult for sperm to reach the egg and for a fertilized egg to implant in the uterus.

When used correctly, Femlyv has been shown to be over 99 percent effective at preventing pregnancy.

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Femlyv’s safety and efficacy data was based on studies that evaluated safety outcomes among individuals taking a combined oral contraceptive (COC) versus those taking a non-COC.

“Femlyv is the first FDA-approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, MD, MHS, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research (CDER).

“There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”

The recommended dosage of Femlyv is one tablet a day for 28 days. It is recommended that the regimen be started on the first day of an individual’s menstrual period or the first Sunday after menstruation onset.

The global contraceptive market size was estimated to be worth $29.57 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 5.92 percent from 2024 to 2030.

Demand for oral contraceptives is growing due to an increasing prevalence of sexually transmitted diseases (STDs), greater education and awareness of modern contraceptives and increasing access to birth control in developing countries.

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