New Birth Control Gel Gets Approval From the FDA | Safer, More Acceptable for Women

The US FDA has approved a new birth control gel as a non-hormonal contraceptive as a safe alternative to the ones already available in the market, and it contains lactic acid, citric acid, and potassium bitartrate. 

In a report, San Diego-based company Evofem Biosciences developed a product that alters the pH levels in the vagina, making it acidic, which then becomes "inhospitable" for the sperm. Named "Phexxi," this new gel has the resemblance of spermicides, which obstruct the entrance to the cervix and cause the sperm to lose speed. 

However, unlike some other birth control devices, it doesn't contain hormones that will cause systemic side effects. Plus, you can take it shortly before having sex. In clinical trials, over 10 percent of women did experience itching and burning, but there was a decrease within each cycle.

The article also mentioned that Phexxi is not to be used by women who have a history of urinary tract infections or urinary tract abnormalities. 

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University of Cincinnati College of Medicine, Department of Obstetrics and Gynecology chair, Michael A. Thomas, MD, explained how Phexxi symbolizes a significant step forward in women's health. "There have been a limited number of advances in birth control over the last two decades," he said.

Dr. Thomas also mentioned an important point on how women can make decisions for their own bodies. 

"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," he explained.

In the clinical studies, which involved 1,400 women, it was noted that the gel prevented pregnancy for 86 percent of the time overall and 93.3 percent when it was used correctly. These findings are stunning, proving much better than condoms and other types of contraceptives available in the market. 

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Phexxi will also have its very own telemedicine support system, which will guide physicians about on-demand education and provide patient access for the product. This ensures that Evofem Biosciences is committed to making all women have access to Phexxi under the Affordable Care Act, or ACA, including those not covered by government or private health plans, and will give a financial assistance program to support qualified candidates. The price per box of 12 gel capsules will run between $250 to $275. 

The contraceptive gel is expected to launch in September, with the company assessing its potential for preventing chlamydia and gonorrhea in women later this year. 

"During my 15-year career at the FDA, I participated in the review and approval of many sexual and reproductive health products, and I believe that Phexxi serves a true unmet need in contraception. Phexxi offers women protection and control--on their terms, and at their discretion--without the use of hormones. I am proud to be a part of this team, and this moment in history," Dr. Lisa Rarick, former FDA Division Director, and Evofem board member, said. 

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