FDA OKs New Combined Oral Contraceptive

The 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 3725 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).

Read the full article on Contemporary OB/GYN.