David Robert Friend
Evofem Biosciences Inc., USA
Title: Amphora® vaginal gel: An on-demand contraceptive with anti-STI (MPT) potential
Biography
Biography: David Robert Friend
Abstract
Amphora® vaginal gel is being developed as an on-demand, contraceptive vaginal gel. Moreover, Amphora has antimicrobial properties and its potential to protect women against some genital infections is being investigated. Amphora was evaluated as a vaginal contraceptive, compared to the commercially available spermicidal gel Conceptrol®, whose activity is derived from the surfactant nonoxynol-9. In addition, studies to investigate the anti-microbial activity of Amphora both in vitro and in animal models (especially the mouse vaginal challenge model) have been conducted. The phase three contraceptive efficacy clinical trial demonstrated that Amphora was non-inferior as a contraceptive compared with Conceptrol. The study confirmed that Amphora gel was non-inferior to Conceptrol under both perfect and typical use participants. There were no serious side-effects with either product. Amphora inactivated all seven gonococcal strains tested in vitro, and in the mouse vaginal challenge model only 1 out of 17 mice pre-treated with Amphora were infected, as compared to 13 out of 15 untreated mice. In similar studies with chlamydia, 3 of 16 mice pre-treated with Amphora were infected, compared to 14 of 16 given placebo. The same model was used in testing Amphora’s ability to protect against vaginal infection with the genital herpes virus (HSV-2); of 26 animals pre-treated with Amphora, five were infected, compared to 22 out of 25 given placebo gel. If the promising antimicrobial findings translate into protection for women in the form, Amphora would be an important multipurpose prevention technology (MPT).