FDA Approves New Oral Contraceptive Nextstellis

The U.S. Food and Drug Administration (FDA) has approved the drug, which is a new combined oral contraceptive (COC) with 3 mg drospirenone (DRSP) and 14.2 mg estetrol (E4). Developed by Mithra Pharmaceuticals, it is the first and only contraceptive pill containing E4. That means it is the first new estrogen introduced in the U.S. in more than 50 years.

Nextstellis will be marketed and distributed by Mayne Pharma, SA, by the end of June 2021.

In Phase 3 clinical trials conducted in 3,725 women, Nextstellis proved to be safe, effective, and demonstrated outstanding cycle control, bleeding control, safety and tolerability, according to reports.

“When speaking with patients about their contraceptive options, one of the most common concerns is side effects,” said Mitchell Creinin, Professor and Director of Family Planning at the University of California in a press release. Clinical results showed a desirable bleeding profile and minimal impact on triglycerides, cholesterol and glucose, and on weight and endocrine markers. Nextstellis also produced significantly lower increases in sex hormone-binding globulin (SHBG) compared to two other contraceptives containing the synthetic estrogen ethinyl-estradiol (EE).

“When prescribing COCs, practitioners must have a good understanding of how these therapies may impact other hormones in the body in order to make an informed prescribing decision for their patients," said Andrew London, M.D., Assistant Professor of ob/gyn at The Johns Hopkins School of Medicine in a recent press release. "Based on our findings, treatment with DRSP/E4 has limited effects on some of these endocrine parameters compared to the tested EE-containing products, giving DRSP/E4 a different and potentially favorable endocrine profile compared to those EE-based COCs."

Because the estrogen in Nextstellis is selective, “it demonstrated a more neutral effect on the liver endocrine parameters than the two reference oral contraceptives that were included in the study: EE combined with either levonorgestrel (LNG/EE) or drospirenone (DRSP/EE),” London recently told Contemporary OB/GYN®. “EE is a very potent estrogen, while E4 is a much weaker estrogen. The smaller rise in SHBG is very exciting and could potentially help with hormone-related libido issues.”