The U.S. Food and Drug Administration (FDA) has approved a plant-based oral contraceptive, Nextstellis, marketed by Mayne Pharma, following a comprehensive clinical study program.
The product will become available by the end of June 2021, the company announced last week in a statement regarding the approval.
The contraceptive was developed by the firm’s manufacturing partner, Mithra Pharmaceuticals, SA., and is named NEXTSTELLIS®.
According to the company, the product is the only oral contraceptive that contains E4, or naturally occurring estrogen that is produced from a plant source. The naturally-occurring E4 estrogen acts differently in the body than EE, or synthetic estrogen said the company and can be described as a native estrogen with selective actions in tissues, or NEST.
“It has more selective activity in tissues, focusing on those needed to support contraceptive efficacy, cycle control and other beneficial effects of estrogen,” reads a statement from the company.
“When speaking with patients about their contraceptive options, one of the most common concerns is side effects,” said Mitchell Creinin, a professor and the director of family planning at the University of California, Davis. “
“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® demonstrated contraceptive efficacy across all subgroups by age, BMI1 and prior hormonal contraception use, the company said in reference to the findings from the phase 3 study. The company says that females who smoke and are more than 35 years old should not use the product, and notes that smoking cigarettes increases the risk of serious cardiovascular events from combination oral contraceptives.