By Mary Hearty and Irene Mbanga
The United States department of Food and Drug Administration (FDA) has approved Annovera (segesterone acetate and ethinyl estradiol vaginal system) for use in family planning options.
Annovera becomes another contraceptive that protects unintended pregnancy in a woman for a period of one year.
The approval marks an important step toward expanding contraceptive options for women. Annovera is able to control pregnancy for twelve months if properly used.
Announcement was made by the Population Council, a global nonprofit research organization, after endorsement by Food and Drug Administration (FDA) a US agency.
The research and development of Annovera have been supported by important public and private donors from around the world.
Donors include the US Agency for International Development (USAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Bill & Melinda Gates Foundation, the Avis and Clifford Barrus Medical Foundation and the World Health Organization (WHO).
According to Ms Julia Bunting, President of Population Council, for more than 60 years, the Population Council has been at the vanguard of global efforts to develop innovative family planning methods that meet women’s needs.
Ms Bunting said a single contraceptive system provides a full year protection for a woman. She disclosed Annovera is in a new class of latest developed contraceptives for family planning options.
“It is a soft, reusable flexible silicone ring (2 ¼ inches diameter) that can be inserted and removed by a woman herself,” Ms Bunting described. Left in place for 21 days and removed for 7 days, its indication to prevent pregnancy for up to a year, no refrigeration requirements, makes it particularly important for distribution and use in low-resource settings hence game-changer for some women.” She affirmed.
Ms Bunting stated according to the Center for Disease Control records, more than 43 million women in the US are at risk of unintended pregnancy. Her observation indicates that women with unintended pregnancies are less likely to receive proper prenatal care and are more likely to have premature and low-birth-weight infants and have increased physical and mental health risks.
On the other hand, Mr James Sailer, Vice President and Executive Director, Center for Biomedical Research at the Population Council, noted the approval is a major step towards introducing the product globally. And again a better choice of meeting sexual and reproductive health needs of women, men and young people in the US and around the world.
“Women with unintended pregnancies are less likely to receive proper prenatal care. They are more likely to have premature and low-birth-weight infants and increased physical and mental health risks,”Mr Sailer, Executive Director cautioned.
Mr Sailer stated providing women with a range of contraceptive options, enhance their family planning needs, helps reduce unintended pregnancy and improves outcomes.
The researcher noted the FDA approval of Annovera is based in part on data from 17 clinical trials, including two pivotal Phase 3 safety and efficacy trials. The phase 3 program enrolled a total of 2,308 women across 27 study sites in the United States, Latin America, Europe and Australia.
Women in the trials were between 18 and 40 years of age and were instructed to use the system over 13 menstrual cycles, or one full year. The data showed that Annovera is 97.3 percent effective in preventing pregnancy when used as directed.
Nearly 9 in 10 women thus 89 percent surveyed were satisfied with it as a method of contraception. Moreover, most of the participants did not experience change in sexual pleasure or frequency of sexual intercourse.
However, it is advised that Annovera should not be used by women with high risk of arterial diseases. Signs or history of breast cancer, liver tumors, acute hepatitis and undiagnosed abnormal uterine bleeding.
Nevertheless, women over age 35 who smoke are encouraged not to use Annovera. This is because cigarette smoking at above this age increases the risk of serious cardiovascular events from combination hormonal contraceptive use.
Professor Anita Nelson, Managing Director and chairperson of Obstetrics and Gynecology at Western University of Health Sciences, expressed her optimism toward Annovera as a new family planning option for women who want greater choice, convenience and control of births.
Professor Anita acknowledged the Population Council for innovatively and cooperatively addressing women’s contraceptive needs over the years.
“It is exciting they are continuing to help empower women with another contraceptive choice.” Prof Anita said.
“This is enabling women to make informed choices about their sexual and reproductive health, provides an opportunity for women to pursue additional education and participate in public life, including paid employment in non-family organizations,” Prof Anita emphasized.
“Having smaller families allows parents to invest more in each child. Children with fewer siblings tend to stay in school longer than those with many siblings,” she added.
Professor Anita explained that giving women across the world access to family planning contraceptives is transformative. Apart from empowering them, it is one of the best investments a country can make in its future for population control.
She clarified contraceptives among women is key to slowing unsustainable population growth and the resulting negative impacts on the economy, environment and national and regional development efforts.
It has also side effects which include headache, nausea and vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.
Annovera will be the sixth contraceptive technology that Population Council researchers have developed to address family planning needs around the world and brought to market through commercialization agreements.
It is likely to be commercially available by the third quarter of 2019 and commercially launched in the fourth quarter of 2019 or first quarter of 2020.
The Population Council is continuing efforts to make Annovera available worldwide, including in low- and middle-income countries where more than 214 million women have an unmet need for contraception.