FDA OKs First Orally Dissolving Birth Control Pill

The FDA has approved the first orally disintegrating birth control pill, the agency announced on Tuesday.

Branded as Femlyv, the product uses active ingredients — norethindrone acetate (a progestin) and ethinyl estradiol (an estrogen) — that have been approved in a swallowable form for more than half a century.

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

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

The dissolving tablets are indicated for females of reproductive potential, though efficacy has not been established for those with a body mass index greater than 35.

Effectiveness of norethindrone acetate and ethinyl estradiol was assessed in 743 women ages 18 to 45 who took the tablets for up to six 28-day cycles. Among the 583 women who completed six cycles of treatment, there were five on-treatment pregnancies within 3,565 total treatment cycles in which no backup contraception was used.

According to the labeling, the most common adverse events associated with norethindrone acetate and ethinyl estradiol include headache (6%), vaginal candidiasis (6%), nausea (5%), menstrual cramps (4%), breast tenderness (3%), bacterial vaginitis (3%), abnormal cervical smear (3%), acne (3%), mood swings (2%), and weight gain (2%). In total, 6% discontinued the trial due to an adverse event.

The product comes in packets of 28 dissolvable tablets, with 24 green colored active doses (1 mg norethindrone acetate, 0.02 mg ethinyl estradiol) and four white inert tablets. To use, patients should let the tablet dissolve on the tongue and then drink 8 oz of water. The tablets should be taken around the same time each day without regard to meals.

Norethindrone acetate and ethinyl estradiol comes with a handful of contraindications, including current or previous breast cancer, high risk of arterial or venous thrombotic diseases, liver tumors or hepatic impairment, abnormal uterine bleeding, and co-administration with certain hepatitis C drugs.

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