FDA approves first oral dissolvable contraceptive pill
The US Food and Drug Administration has approved a mouth dissolving hormonal birth control pill for people who have trouble swallowing.
The approval is based on positive results from a study involving 743 women ages 18 to 45 who received the tablets for up to 6 28-day cycles. At the end of the 6 cycles, 5 of the 583 women had on-treatment pregnancies within 3,565 treatment cycles.
Contraceptive pills are hormonal treatment commonly used to prevent pregnancy. Further they have other beneficial applications in managing endometriosis, polycystic ovary syndrome, menstrual symptoms, irregular menstrual cycles, and premenstrual dysphoric disorder (PMDD). Many of these conditions can be debilitating with significant quality of life implications for affected individuals. Hormonal contraceptives may have either 1 or a combination of estrogen and progestin and are available as oral medications, patches, injections, and intrauterine devices.
The FDA has approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Earlier Norethindrone acetate and ethinyl estradiol main ingredients in Femlyv, had been approved in U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
"Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication," said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA's Center for Drug Evaluation and Research. "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 most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.
