Evofem Biosciences Inc.'s resubmission for approval of nonhormonal contraceptive gel Amphora has been received by the U.S. Food and Drug Administration and given a decision date of May 25, 2020.
The San Diego-based company's second application for approval is based on phase 3 trial results that showed Amphora had an 86% efficacy rate in preventing pregnancy, Evofem said in a Dec. 18 press release.
The FDA had previously rejected Amphora in 2016 due to patient data issues.
Amphora is a gel intended to regulate vaginal pH and is also being tested to prevent sexually transmitted diseases, including gonorrhea and chlamydia.
Few new contraceptives have come to market, an issue that advisers to the FDA have pointed out. If approved, Amphora would join diaphragms, condoms and copper intrauterine devices as a nonhormonal contraceptive option for women.