FDA Makes Historic First Approving NEXTSTELLIS, an Oral Contraceptive Containing E4


The approval, which was awarded to Mayne Pharma, makes NEXTSTELLIS the first and only contraceptive pill containing E4, a natural occurring estrogen to receive approval from the FDA.

This article originally appeared on HCPLive.com.

FDA logo

Mayne Pharma has announced the US Food and Drug Administration (FDA) granted approval to their 3 mg drospirenone [DRSP] and 14.2 mg estetrol [E4] tablets (NEXTSTELLIS) for use as an oral contraceptive.

The approval represents the first and only contraceptive pill containing E4, a natural occurring estrogen, now produced from a plant source. The substance has a unique mechanism of action that offers potential advantages over other estrogens.

The Product

E4 represents the first estrogen that is a native estrogen with selective actions in tissues (NEST), with more selective activity in tissues, focusing on those needed to support contraceptive efficacy, cycle control and other beneficial effects of estrogen.

The product pairs with E4, which has a 24-28 hour half-life, with the proven progestin drospirenone, specifically chosen due to its long half-life (~30 hours) and its anti-androgenic and anti-ineralocorticoid properties.

Clinical Trials

The approval is based on a clinical study program that included a diverse patient population with women both starting and switching birth control, as well as patients with a body mass index (BMI) of up to 35 kg/m2.

There are nearly 10 million women in the US who use short-acting combination contraceptives, 99% of which contain ethinyl estradiol (EE), a synthetic estrogen that binds widely to all estrogen receptors in the body.

"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, Davis, in a statement. "NEXTSTELLIS is an innovative contraceptive that has been shown to be not only safe and effective, but also well tolerated in clinical trials with a desirable bleeding profile and minimal impact on triglycerides, cholesterol, and glucose, as well as weight and endocrine markers."

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