Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA announced the US commercial launch of NEXTSTELLIS® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets), a new oral contraceptive with a novel estrogen having a unique mechanism of action. NEXTSTELLIS was approved by the FDA in April 2021 and is the first and only pill containing E4, a natural estrogen produced during pregnancy that is now synthesised from a plant source. E4 is the first new estrogen introduced in the US in over 50 years.

NEXTSTELLIS will compete in the short-acting combination hormonal contraceptive (estrogen and progestin) market which is valued at US$3.5 billion1. Nearly 10 million American women use combination oral contraceptives, patches or vaginal rings every day. Of these contraceptives, more than 99% contain ethinyl estradiol, a synthetic estrogen that binds widely to all estrogen receptors in the body.

E4 acts differently than other estrogens and is the first natural estrogen with selective action in tissues focusing on those needed to support contraceptive efficacy, cycle control, and other beneficial effects of estrogen. Its unique pharmacologic profile includes excellent oral bioavailability and a long half-life2.