The United States Food and Drug Administration has approved a non-hormonal contraceptive gel that has been shown to be 86% effective in tests. It is the first fully non-hormonal contraceptive option to be validated in almost 30 years.
This Friday, May 21, the Food and Drug Administration (FDA) approved in the United States a new contraceptive gel for women which was 86% effective in the tests carried out. This non-hormonal contraceptive for women, called Phexxi, was created by the company Evofem Biosciences, based in San Diego, California. It is a vaginal gel that is inserted using a cylindrical applicator up to one hour before intercourse. The gel contains lactic acid, citric acid and potassium bitartrate, common food additives.
If this gel has similarities to spermicides, which block the entry of the cervix and slow down sperm, it works differently. It stabilizes the pH of the vagina in a range between 3.5 and 4.5, creating a totally inhospitable environment for sperm which cannot then survive.
In a study of 1,400 women aged 18 to 35, Phexxi has been shown to be approximately 86% effective on average over seven menstrual cycles and over 34,000 total sexual relationships. This is a better result than for condoms, spermicides and other contraceptives "on demand", but the gel remains less effective than long-term methods like intrauterine devices (IUDs).
Unlike some other contraceptives, it should only be used shortly before intercourse and does not contain hormones, which limits side effects. Currently approved hormone products can cause side effects like pain, weight gain, headache and bleeding. Oral contraceptives can sometimes cause blood clots and heart problems, including heart attacks.
Phexxi is a unique product on the current contraceptive market. FDA approval of Phexxi East a victory for women's health, according to Saundra Pelletier, Executive Director ofEvofem Biosciences. "FDA approval of Phexxi means that women now have access to a non-hormonal contraceptive option that they control, according to their conditions, so that it is used ONLY when they need it.", she said in a statement.
Side effects of Phexxi would be mainly minor irritations and burns, which decreased significantly after repeated use. They concerned only very few cases, around 0.36%.
"During my 15-year career at the FDA, I have participated in the review and approval of many sexual and reproductive health products, and I believe that Phexxi responds to a truly unmet need for contraception. Phexxi offers women protection and control – on their terms and in complete discretion – without using hormones."says Lisa Rarick, former FDA division director and board member ofEvofem.
The Food and Drug Administration approved the Phexxi only as a contraceptive, but Evofem affirm that his tests indicate that the gel also reduces the risk of infection with gonorrhea and chlamydia.