Mayne Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved NEXTSTELLIS (3 mg drospirenone [DRSP] and 14.2 mg estetrol [E4] tablets) for the prevention of pregnancy. NEXTSTELLIS is the first and only contraceptive pill containing E4, a naturally occurring estrogen, now produced from a plant source, with a unique mechanism of action that offers potential advantages over other estrogens.
NEXTSTELLIS is the only oral contraceptive to contain E4; E4 acts differently than other estrogens and is the first estrogen to be described as a NEST: A Native Estrogen with Selective actions in Tissues. It has more selective activity in tissues, focusing on those needed to support contraceptive efficacy, cycle control and other beneficial effects of estrogen. NEXTSTELLIS pairs E4, which has a long half-life (24-28 hours), with the proven progestin drospirenone, specifically chosen due to its long half-life (~30 hours) and its anti-androgenic and anti-mineralocorticoid properties.
“The approval of NEXTSTELLIS represents an important milestone in providing women with another choice for their reproductive health,” said Scott Richards, CEO of Mayne Pharma. “We are delighted to be introducing a new estrogen and bringing to market this novel, safe and effective option for women to consider with their healthcare providers.”
NEXTSTELLIS was developed by Mayne Pharma’s development and manufacturing partner, Mithra Pharmaceuticals, SA. The company anticipates the commercial launch of NEXTSTELLIS by the end of June 2021.