21 February 2018 - Evofem Biosciences today announced that the U.S. FDA has granted fast track designation for Amphora (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of urogenital chlamydia in women.

The clinical development program for Amphora in prevention of STIs includes an ongoing double-blinded placebo-controlled Phase 2b/3 study to evaluate the efficacy of Amphora in preventing urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women when applied up to one hour prior to vaginal intercourse. This study is designed to enrol approximately 850 women at up to 20 centers in the United States. Subjects will be evaluated during a four-month interventional period and subsequent one-month follow-up period.

Read Evofem Biosciences press release