Estelle® oral contraceptive now available in the United States
Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA are very pleased to announce the US commercial launch of Estelle® under the trademark 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 nearly EUR 3 billion (1). About 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-life (2).
“We are delighted to launch Nextstellis, a new birth control option for women and their healthcare providers. Every woman’s body reacts differently to hormones and so from today, American women will now have a new choice of estrogen to consider when thinking about birth control options,” said Mayne Pharma’s CEO, Mr. Scott Richards. “Our key priorities with this launch are to educate the market on the benefits of Nextstellis and the new estrogen E4, gain broad payor acceptance and reimbursement, and ultimately become the preferred branded oral contraceptive in the market. The launch is supported by a highly experienced national Women’s Health sales team that is now actively promoting Nextstellis to healthcare providers.”
Mithra’s CEO Mr. Leon Van Rompay said, “The launch of Nextstellis today represents a new era in contraception and we are proud to have played a part in helping to support women and their healthcare providers in their contraceptive choices. Mithra is excited to see the commercialisation of Nextstellis in the world’s largest pharmaceutical market.”
(1) IQVIA, MAT Sales, April 2021
(2) Coelingh Bennink HJ, et al. Climacteric. 2008;11(suppl 1):47-58; Visser M, et al. Climacteric. 2008;11(suppl 1):31-40; Clinical study report MIT‐Es0001‐C103; Coelingh Bennink HJ, et al. Climacteric. 2008;11(suppl 1):2-14