FDA approves first on demand vaginal gel for contraception
FDA approves new class of female-controlled Birth Control for use In-the-moment -a safe,convenient non hormonal vaginal gel.;
Food and drug Administration (FDA) has approved first non hormonal contraceptive vaginal gel for use as an on-demand method of contraception. Composed of lactic acid, citric acid, and potassium bitartrate (Phexxi) the gel demonstrated an efficacy rate of 86.3% during a phase 3 clinical trial for the prevention of pregnancy.
Phexxi is a 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.
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. "Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change."
"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. "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."
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