FDA approves novel oral contraceptive pill
The FDA approved a combination drospirenone and estetrol tablet for the prevention of pregnancy, the first combination pill containing naturally occurring estrogen, according to an industry press release.
The combination tablet (Nextstellis, Mayne Pharma) is the first and only contraceptive pill containing 3 mg drospirenone and 14.2 mg estetrol, a naturally occurring estrogen produced from a plant source. The pill has a “unique mechanism of action that offers potential advantages over other estrogens,” according to the company.
“When speaking with patients about their contraceptive options, one of the most common concerns is side effects,” Mitchell D. Creinin, MD, professor and director of family planning at the University of California, Davis, said in the release. “Nextstellis is an innovative contraceptive that has been shown to be not only safe and effective, but also well tolerated in clinical trials with a desirable bleeding profile and minimal impact on triglycerides, cholesterol and glucose, as well as weight and endocrine markers.”
Nextstellis tablets are the only oral contraceptive to contain estetrol; described as a native estrogen with selective actions in tissues. The tablet pairs estetrol, which has a long half-life (24-28 hours), with the progestin drospirenone, chosen due to its long half-life of 30 hours and its anti-androgenic and anti-mineralocorticoid properties, according to the company.
“The approval of Nextstellis represents an important milestone in providing women with another choice for their reproductive health,” Scott Richards, CEO of Mayne Pharma, said in the release. “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 health care providers.”
The Nextstellis clinical study program included a population of women both starting and switching birth control as well as participants with a BMI up to 35 kg/m². In a phase 3 study, the combination pill demonstrated contraceptive efficacy across all subgroups by age, BMI and prior hormonal contraception use. The tablet was also associated with a favorable bleeding profile and low rates of breakthrough bleeding, including in the first cycle.
Mayne Pharma's development and manufacturing partner, Mithra Pharmaceuticals, developed Nextstellis. The company said a commercial launch will take place in June.