Evofem Biosciences sought FDA’s Fast Track designation for Amphora vagina gel

Biotechnology company developing innovative products to fill women’s unmet healthcare needs, Evofem Biosciences asserted that the U.S FDA has extended Fast Track designation for Amphora (L-lactic acid, citric acid, and potassium bitartrate) vagina gel to forbid urogenital chlamydia in women.

Amphora is primarily an investigational drug being evaluated for the prevention of certain sexually transmitted infections (STIs) and as an on-demand, non-hormonal vaginal contraceptive. The fast track designation is designed to facilitate the development and enhance the review of new therapies to treat serious conditions and satiate unmet medical needs.

Approximately 1.6 million new cases were reported in 2016 alone, an increase of 4.7% from the prior year.  While treatment with antibiotics is effective, repeat infection is common. Multiple chlamydial infections increase a woman’s risk of serious reproductive health complications including pelvic inflammatory disease and ectopic pregnancy.

Dr. Kelly Culwell, Evofem’s Chief Medical Officer said “We look forward to working closely with the FDA to facilitate the development of this preventive therapeutic.”

The program includes 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.

Evofem is also developing Amphora as an on-demand, non-hormonal vaginal contraceptive. The company enrolled in its single-arm, open-label, Phase 3 clinical trial. The study is implied to evaluate the contraceptive efficacy and safety of Amphora in approximately 1,350 women aged 18-35 years who are likely to impregnate.

Saundra Pelletier, Evofem Biosciences’ CEO said “While each of these women’s health issues is important in its own right, Amphora holds even greater promise as a potential combined preventive therapy for all three, which we believe could revolutionize women’s health.”