FDA Approves First Non-Hormonal Contraceptive Gel

Birth control either stops an egg from being released into the womb, sperm from reaching the egg or a fertilized egg from implanting in the womb. There're so many hormonal and non-hormonal options when you’re looking for the right contraceptive method for you. While the pill is still the most popular form of female contraception, new types of birth control are still being developed. The FDA approved the first non-hormonal prescription birth control gel. It works by maintaining your vaginal pH within the normal range which is acidic and inhospitable to sperm.

The U.S. Food and Drug Administration (FDA) approved Phexxi on May 22. Made up of lactic acid, citric acid and potassium bitartrate, it comes in the form of a gel that comes with an applicator and can be inserted into the vagina shortly before sex. Developed by Evofem Biosciences, Inc, the gel is non-hormonal and works in a similar way to spermicide. 

Many things can affect the pH of your vagina, including sperm. Generally, it should have a pH level between 3.5 and 4.5 making it acidic. However, sperm raises the pH to around 7 or 8 making it neutral. Phexxi was developed to maintain the natural pH levels in your vagina so sperm can’t survive. 

"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 haven’t 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."

Phexxi was tested on 1,400 women who were aged between 18 to 35. It was 86 percent effective on average over seven menstrual cycles. A small minority of women suffered from cystitis, pyelonephritis, and UTI’s afterward and Evofem has suggested that Phexxi isn’t suitable for people with a history of recurrent urinary tract infections or urinary tract abnormalities.

It’s been reported that Phexxi will cost $250 to $275 for a box of 12 without insurance and the company is working to have it covered under the Affordable Care Act. Evofem Biosciences' Chief Executive Officer, Saundra Pelletier said in a statement, “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. We’re proud and excited to deliver new innovation to women in a category ready for change."

It’s expected that Phexxi will be launched in early September. Taking into consideration the current Covid-19 pandemic, Phexxi Concierge Experience will be available alongside it. Evofem describes this as “a patient and healthcare provider telemedicine support system.” The company has said that through the platform people would be able to secure a prescription, determine their insurance coverage, receive counseling support and refill reminders.

While Phexxi works to protect you against pregnancy it doesn’t shield you from STIs. It’s important to speak to your clinician before you change birth control.