Nextstellis Approved as a Contraceptive

April 16, 2021 – The U.S. FDA has approved Nextstellis® (3mg drospirenone/14.2mg estetrol tablets), manufactured by Mayne Pharma, for use by females of reproductive potential to prevent pregnancy. The product is the first and only FDA-approved contraceptive pill that contains estetrol, a non-synthetic type of estrogen derived from a plant source. Estetrol is the first new form of estrogen introduced in the U.S. in more than 50 years.

An estimated 10 million women in the United States use short-acting combination contraceptives such as Nextstellis. These contraceptives combine estrogen and progestin hormones – which in Nextstellis is achieved using drospirenone (a progestin) and estetrol – to prevent pregnancy by preventing the release of eggs and making it harder for sperm to fertilize any eggs that may be present. They are an easily reversed contraceptive, with women able to conceive soon after stopping the medication. Combination contraceptives may also provide health benefits such as reducing the risk of certain cancers, ovarian cysts, ectopic pregnancy, and iron-deficiency anemia related to menstrual bleeding.

In clinical trials, Nextstellis was found to be safe, effective, and well-tolerated. Unlike the majority of combined contraceptives, which contain a synthetic estrogen called ethinyl estradiol, Nextstellis uses an estrogen that is more selective in how it affects the body’s tissues. This may provide patients with a choice of birth control that lowers the risk of side effects related to the use of combination contraceptives.

Recommended dosing is one tablet taken by mouth at the same time every day, in the order directed on the blister pack. Each pack contains 28 tablets, with pink active tablets taken for the first 24 days, followed by white inert tablets taken on the last four days of each 28-day treatment cycle.

A black box warning cautions that cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. The risk increases with the number of cigarettes smoked and with age – particularly in females who are more than 35 years old. Nextstellis and other CHCs are contraindicated in females over 35 years of age who smoke.

Nextstellis has launched at a wholesale acquisition cost (WAC) of $190 for 28 tablets.