July 31, 2018—Today the Population Council announced a new license agreement with TherapeuticsMD to make available the Council’s investigational segesterone acetate/ethinyl estradiol one-year vaginal system for contraception, to women in the United States. The agreement marks an important step toward expanding contraceptive options for women.
A New Drug Application (NDA) for the one-year vaginal contraceptive system is currently under review by the U.S. Food and Drug Administration (FDA). If approved, the vaginal contraceptive system would be the first and only reversible contraceptive option that provides a full year of protection against unintended pregnancy while fully under a woman’s control.
“For more than 60 years, the Population Council has been conducting biomedical research and developing products to advance sexual and reproductive health and wellbeing around the world,” said Julia Bunting, president of the Population Council. “By working with diverse organizations, we have been able to develop and introduce many of the most effective and widely used contraceptive technologies available today, allowing millions of women and couples to decide freely and for themselves, whether, when and how many children to have.”
TherapeuticsMD is an innovative healthcare company focused on developing and commercializing novel products exclusively for women. As part of the license agreement, TherapeuticsMD will provide significantly reduced pricing to federally designated Title X family planning clinics serving lower-income women.
“This agreement represents exciting progress in our efforts to bring women around the world an important new addition to the suite of contraceptive options,” said Jim Sailer, executive director of the Center for Biomedical Research at Population Council. “We are very grateful to the dedicated researchers who have contributed to the development of this product and pleased to have a committed company like TherapeuticsMD provide it to women in the United States.”
Regulatory review by the FDA is considered a key step in the pathway toward global availability. If approved by the U.S. FDA, the vaginal contraceptive system would be the sixth technology to prevent unintended pregnancy that the Population Council researchers have brought to market through commercialization agreements. The Population Council has previously developed long-acting, reversible contraceptive products including intrauterine devices ParaGard® and Mirena®; implants Norplant® and Jadelle®; and Progering®, the contraceptive vaginal ring for breastfeeding women.
Proceeds from licensing agreements are reinvested in the Population Council’s work around the world, including into biomedical research and development programs. More than 170 million women worldwide are currently using highly effective contraceptives developed by the Population Council or based on our technologies.
In addition to Population Council resources, key donors from around the world have supported the research and development of the vaginal contraceptive system.