Mayne Pharma, Mithra Pharmaceuticals debut Nextstellis

Mayne Pharma and Mithra Pharmaceuticals are launching 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.

“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 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 Nextstellius to healthcare providers.”

Nextstellis, approved by the Food and Drug Administration in April, is the first and only pill containing E4, a natural estrogen produced during pregnancy that is now synthesized from a plant source. E4 is the first new estrogen introduced in the United States in over 50 years, the company 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’s CEO Leon Van Rompay said. "Mithra is excited to see the commercialization of Nextstellis in the world’s largest pharmaceutical market."