PhexxiTreatment for Contraception
Update: Phexxi (lactic acid, citric acid, and potassium bitartrate) Vaginal Gel Now FDA Approved - May 25, 2020
Evofem, Inc. Submits NDA to U.S. FDA for Amphora as a Contraceptive
San Diego, CA, July 6, 2015 – Evofem, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Amphora as a contraceptive vaginal gel for women. The submission is based on the results of a large, multicenter, open-label, randomized, phase III trial that examined the repeated use of Amphora gel compared to a vaginal gel containing Nonoxynol-9 as the primary method of contraception over seven cycles of use.
“Evofem is committed to our mission of empowering women by providing new innovations in women’s health and more ways for women to manage their fertility,” said Saundra Pelletier, Chief Executive Officer of Evofem, Inc. “Based on the results of the phase III trial, we believe Amphora can become an important and exciting new product for women and address a large unmet need in the market because it is woman-controlled, pericoital and hormone-free.”
Amphora is a non-hormonal vaginal gel. In addition to submission for approval as a contraceptive, Amphora is being investigated for microbicidal properties to develop a potential multipurpose prevention technology. Amphora works by restoring the vaginal pH levels to those consistent with a healthy vaginal environment which acts against both semen as well as viral and bacterial pathogens.
About Evofem, Inc.
Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections. Evofem, Inc. is committed to delivering effective, woman-controlled, rapidly reversible forms of contraception to women globally.
Source: Evofem, Inc.
Posted: July 2015
- FDA Approves Phexxi (lactic acid, citric acid and potassium bitartrate) Non-Hormonal Prescription Gel for the Prevention of Pregnancy - May 22, 2020
- U.S. FDA Acknowledges Receipt of Evofem Biosciences' New Drug Application Resubmission for Amphora for the Prevention of Pregnancy - December 18, 2019
- Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy - November 26, 2019
- Evofem Biosciences Receives Fast Track Designation for Amphora for Prevention of Chlamydia - February 21, 2018
- Evofem, Inc. Announces FDA Acceptance of New Drug Application for Amphora as a Contraceptive - September 22, 2015
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