Mayne Pharma has submitted an NDA to the U.S. FDA seeking marketing authorization for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy.

E4/DRSP is a novel, next-gen oral contraceptive containing Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. E4 is a naturally occurring estrogen that is produced by the human fetal liver during pregnancy. Following more than 20 years of research and development, Mayne Pharma’s development and manufacturing partner Mithra Pharmaceuticals can synthesise E4 at scale through a complex plant-based production process.

Mayne Pharma’s CEO Scott Richards said, “The NDA filing is a major milestone for Mayne Pharma and our development partner Mithra Pharmaceuticals. We are now one step closer to making this new oral contraceptive that we believe to be safe, effective and well-tolerated available to American women. We confirm our earlier stated goal of bringing this product to market in the first half of calendar 2021.”