Newly FDA-Approved Contraceptive Gel is Not Your Momma’s Spermicide

In the years that the IUD and birth control pill have become more popular, spermicide and spermicide-adjacent methods (diaphragms and caps included) have fallen out of vogue. However, a newly approved non-hormonal contraceptive gel from Evofem Biosciences might end up being part of a new renaissance for the old method — particularly for people who are looking for non-hormonal options that optimize individual control.

Cited as “the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm,” Phexxi is likely to launch in early September as a prescription vaginal gel that can be used to prevent pregnancy.  They are also working to have it be covered under the Affordable Care Act (ACA), which requires that private health plans provide coverage for one treatment per FDA-identified class in their Birth Control Guide.

“There have been a limited number of advances in birth control over the last two decades; Phexxi represents an important step forward in women’s health,” said Michael A. Thomas, M.D., Chair of the Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine in a statement. “Many of my patients have cycled through numerous contraceptive options and still have not found the right fit for their sexual and reproductive needs. Phexxi offers women freedom from hormones and control over how they choose to prevent pregnancy. I look forward to offering this new on-demand option to my patients.” 

With a tampon-like applicator meant to be used immediately (or within an hour) before intercourse, Phexxi works to keep the pH of the vagina in a range that is less hospitable to sperm trying to move toward an egg (since sperm typically changes the vagina’s pH to be better for them to swim). 

“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,” said Saundra Pelletier, Evofem Biosciences’ Chief Executive Officer in a statement. “Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change.”

According to a release, the company plans to launch Phexxi with a partnering “telemedicine support system called the Phexxi Concierge Experience. “This robust offering of services is designed to provide physicians with on-demand educational support, and speed and simplify women’s access to Phexxi. Through this offering, women would be able to secure a prescription, determine their insurance coverage and/or out-of-pocket costs, receive counseling support and refill reminders, and fill their prescription through their local neighborhood pharmacy or an online pharmacy that is expected to deliver Phexxi right to their door.”

How effective is it really

As Planned Parenthood notes, spermicides are statistically not an effective method to be used alone — and don’t offer protections from Sexually Transmitted Infections (STIs) that come with barrier methods: “Used alone, spermicides are among the least reliable methods of birth control — even with perfect use, they are only up to 85 percent effective against pregnancy, and they offer no protection against sexually transmitted infections. They are good backup, though, for condoms and pulling out.”

While notably Phexxi does not contain the chemical nonoxynol-9 — which Planned Parenthood notes is used in most spermicides and can, with frequent use put “people at risk for HIV, or for anal sex, may irritate tissue and increase the risk of HIV and other infections.” 

However, as TODAY reports Phexxi works “86.3% of the time,” according to Dr. Kelly Culwell, chief medical officer at Evofem (with data including people who used it too early or forgot to use it at all.) Adding that with ideal use and pairing it with condoms and diaphragms it can be more effective (and condoms have the additional protection against STIs that folks engaging with more than one non-monogamous partner should never forget!)  

Generally, there are other non-hormonal options for birth control — including some IUDs — that leave less room for human error. 

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