FDA Approves First Dissolvable Birth Control Pill

In July, the FDA approved the first orally dissolvable pill for the prevention of pregnancy. The main ingredients in the disintegrating tablet, norethindrone acetate and ethinyl estradiol, were first approved in the United States in 1968.

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

The prescribing information noted that while the tablets are indicated for women of reproductive potential, efficacy was not established for those with a BMI greater than 35.

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Researchers established the efficacy of norethindrone acetate and ethinyl estradiol in a clinical trial examining 743 women aged 18 to 45 who took the tablets for as many as six 28-day cycles. A total of 583 women completed the six cycles of treatments, of which there were five on-treatment pregnancies out of 3565 treatment cycles.

According to the prescribing information, the most common adverse reactions in clinical trials were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.

Reference:
FDA Roundup: July 23, 2024. News release. US Food and Drug Administration; July 23, 2024. Accessed July 29, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-july-23-2024.