A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals Nextstellis cleared as first new oral contraceptive in over 50 years
Mayne’s Nextstellis (drospirenone and estetrol [E4] tablet) has been approved for the prevention of pregnancy in individuals of reproductive potential.
Nextstellis was approved based on efficacy findings from the year-long phase 3, prospective, multicenter, open-label, single-arm E4 Freedom clinical study in the US and Canada. The participant population was diverse, aged 16 to 35 years, and included patients with a body mass index (BMI) of up to 35 kg/m2. The study drug showed contraceptive efficacy across all groups – age, BMI, and previous hormonal use. The overall Pearl index (a measure of effectiveness of a birth control method) was 2.65 per 100 woman-years of use, although there was a trend of decreasing effectiveness with increasing BMI. It was also associated with a favorable bleeding profile and low rates of breakthrough bleeding, including during the first cycle. The top three adverse events were mood disturbance, in 10.9% of patients; bleeding irregularities (9.7%); and breast symptoms (5.3%).
The combination tablet is the only approved contraceptive pill containing estetrol, an estrogen produced by the fetal liver and detectable in humans only during pregnancy. Nextstellis contains plant-sourced E4. Estetrol may have fewer off-target effects on breast and liver tissue. Like drospirenone, a synthetic progestin, estetrol has a long half-life.
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