On May 22, the FDA approved Phexxi, a non-hormonal contraceptive gel used for “the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.” The drug is the first of its kind, working by changing vaginal pH to make the vaginal environment more acidic, and therefore inhospitable to sperm. The drug lowers vaginal pH to approximately 3.5 to 4.5, which Evofem Bioscience (the drug company which owns Phexxi) says is “within normal range.” The gel was shown to have a pregnancy prevention efficacy rate of 86.3 percent during Phase 3 clinical trials.
“Phexxi offers women freedom from hormones and control over how they choose to prevent pregnancy,” Evofem states.
What is Phexxi made of?
Phexxi is a hormone-free combination of lactic acid, citric acid, and potassium bitartrate–more commonly known as cream of tartar, a byproduct of winemaking. In fact, a quick trip to a wine- or cheese-making shop could provide you with all of the active ingredients of Phexxi. The gel comes in a pre-filled, single-dose, single-use, vaginal applicator, which is inserted prior to intercourse to prevent conception.
During clinical trials, the most common side effects experienced by women using Phexxi were: vulvovaginal burning sensation, vulvovaginal pruritus (itching), vulvovaginal mycotic infection, urinary tract infection (UTI), vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain. Rarer complications included cystitis, pyelonephritis and other upper urinary tract infection. Women with a history of recurrent UTIs are discouraged from using Phexxi.
How much does Phexxi cost?
The estimated cost of Phexxi without insurance is $250 to $275 for a box of 12 pre-filled applicators, but Evofem is pushing for coverage under the Affordable Care Act.
“The FDA approval of Phexxi means women now have access to a non-hormonal contraceptive option that they control, on their terms, to be used ONLY when they need it,” Evofem Biosciences CEO Saundra Pelletier said In a press release issued to mark the drug’s approval. “Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change.”
Real non-hormonal options for natural birth control
It is true that women need more choices for family planning beyond hormonal birth control, which has numerous unsavory side effects and health risks from blood clots to cancer. The makers of Phexxi clearly recognized women’s growing desire for family planning options that are safer, immediately reversible (unlike the birth control shot, implants, or IUDs), and that can prevent pregnancy without synthetic hormones.
But the truth is, there are already non-hormonal options for family planning with better effectiveness rates than Phexxi, which are not only lower in cost, but also have no side effects. For one, the Natural Cycles app, the first contraceptive app approved for pregnancy prevention by the FDA in 2018, cites research that women who use the app to avoid pregnancy have a 99 percent perfect-use effectiveness rate, and 93 percent for typical use.
Natural Cycles is an app based on charting a woman’s menstrual cycle. By charting her biological signs of fertility, a woman can know with great accuracy when she can get pregnant–and, when she can’t. Gone are the days of the Rhythm Method; now scientists and doctors have developed researched-backed methods that, according to the CDC, can be as effective as 98 percent in preventing pregnancy.
Fertility Awareness Based Methods (FABM) are non-hormonal methods of family planning by nature, have no side-effects, and many methods are far more effective than Phexxi. Often called natural family planning (NFP) or natural birth control, a FABM helps a woman to learn more about her body’s cycle while practicing effective family planning, with effectiveness rates that depend on the method she learns from an instructor. What’s more, FABMs are much more affordable and sustainable than the current exorbitant price of Phexxi. Who can reasonably afford to pay $20+ for pregnancy prevention every time they have sex?
We already know that our fertility operates in a delicate balance—and as our recent series “Reasons Women Need Periods” has shown, you can’t simply alter one aspect of your reproductive system (such as vaginal pH, for example), and expect that it won’t have effects on other systems and functions.
If you’re looking for hormone-free alternatives to birth control, you might find that your time and money are better spent learning an evidence-based Fertility Awareness Based Method from an instructor.
