FDA Approves First Non-Hormonal Birth Control Gel (2024)

Until last month, there hadn't been any major innovation in non-hormonal birth control since the IUD was invented in the 1970s. But on May 22, the Food and Drug Administration (FDA) approved a new non-hormonal option for women: a prescription birth control gel.

Phexxi, developed by biopharmaceutical company Evofem Biosciences, is considered an "on-demand" type of birth control, meaning you only use it when you need it.

The contraceptive is scheduled for release in early September.

How Does It Work?

Like spermicides, Phexxi needs to be inserted vaginally before sex. But unlike spermicides, which block the entrance to the cervix and slow down sperm so they're not powerful enough to reach the egg, Phexxi works by changing the pH of the vagina during sex to prevent pregnancy.

Normally, the vagina is very acidic—around 3.5 to 4.5 on the pH scale—and not a place sperm could survive on their own. However, sperm-containing semen has a pH of 7.2 to 8.0, and introduces an alkalizing effect when it enters the vagina in order to survive. Phexxi, which is made from a combination of lactic acid, citric acid, and potassium bitartrate, works against this alkalizing effect and keeps the vagina in the acidic range.

"This is designed to make the vaginal environment for the sperm less hospitable," FeliceGersh, MD, OB-GYN, founder and director of the Integrative Medical Group of Irvine in Irvine, CA, told Verywell Health via email. "It isn't a direct poison to the sperm, but [sperm] will not function in a viable manner, in most cases."

What Are the Benefits of Non-Hormonal Birth Control?

Because Phexxi works by creating a hostile environment for sperm, it functions differently from hormonal birth control like pills, vaginal rings, and injections, which are intended to stop the ovulation process each month.

Gersh added that non-hormonal options like Phexxi offer the benefit of not disrupting hormonal rhythms essential for reproductive and metabolic health.

Phexxi also offers the benefit of not relying on external condom use to prevent pregnancy.

"The FDA approval of Phexxi means women now have access to a non-hormonalcontraceptive option thattheycontrol, ontheirterms, to be used only whentheyneed it," Saundra Pelletier, CEO of Evofem Biosciences, said in a statement.

How Do You Take It?

You only need to take Phexxi when you need it. It can be taken immediately before or up to one hour before sex.

The gel comes in a single-dose, pre-filled applicator that's inserted into the vagina directly. Each dose is only effective for one sexual episode. That means you have to insert a new dose for each separate time you have sex, even if both times are within five minutes.

According to Gersh, Phexxi "requires thoughtful use and preparation," so it's best suited for women who are prepared for some level of forethought.

Phexxi, which comes in a box of 12, will only be available through a prescription. If your insurance doesn't cover it, it will cost about $250 to $275 per box, or $20 to $23 per dose.

Is It Effective?

Since Phexxi is still new—and not yet available to the general public—more research is needed to determine how effective it is at preventing pregnancy. So far, a clinical trial of 1,400 women between the ages of 18 to 35 found Phexxi to be 86.3% effective.

To put that into perspective, here's how other birth control methods stack up when it comes to effectiveness:

• Implant: 99.95%
• Hormonal IUD: 99.8%
• Non-hormonal IUD: 99.2%
• Injection: 94%
• Birth control pills: 91%
• Patch: 91%
• Ring: 91%
• Diaphragm: 88%
• External condom: 82% on average, 98% if used perfectly
• Internal condom: 79%
• Withdrawal: 78%
• Fertility awareness methods (like the Rhythm Method): 76%
• Spermicide: 72%

This means, when used perfectly, Phexxi lands somewhere in the middle.

"That's not necessarily what I would consider a reliable contraceptive," Serena H. Chen, MD, director of reproductive medicine at the Institute for Reproductive Medicine and Science (IRMS) at St. Barnabas, in Livingston, NJ, told Verywell. "There’s still a 13.7% pregnancy rate at the end of seven menstrual cycles—nowhere near the pill or an IUD. If you use condoms perfectly, they might actually be better."

Unlike condoms, which also protect against sexually-transmitted infections (STIs), Phexxi is approved as a birth control only.

Are There Side Effects?

Phexxi's most common side effect—vaginal burning—is uncommon with other types of contraceptives. During the clinical trial, 18% of users experienced vaginal burning, while 14.5% reported vaginal itching.

Other reported side effects include:

• Vaginal infection
• Urinary tract infection
• Vaginal discomfort
• Bacterial vaginosis
• Vaginal discharge
• Genital discomfort
• Painful urination
• Vaginal pain

Ultimately, it's important to talk to your healthcare provider about potential birth control benefits and side effects to determine what works best for you.

"I think it’s great to have another choice in the market," Chen said. "But the bottom line is that women really have to take charge of their own bodies and their own health and actually see a doctor."

A Word From Verywell's Medical Expert Board

"Phexxi is a new vaginal gel contraceptive. It is female-controlled and on-demand, meaning you only use it when you need it. Many women may like the fact that it is non-hormonal. This means it may have fewer side effects. But if you decide to try it, know that it is probably not as effective as IUDs or the pill. It also will not protect against STIs." — Anju Goel, MD, MPH