Evofem Biosciences’ lead product candidate, Amphora® is an MPT – more specifically, a Multipurpose Vaginal pH Regulator (MVP-RTM) – that is being developed for the prevention of pregnancy and certain sexually transmitted infections (STIs), including chlamydia and gonorrhea.
Amphora is a non-hormonal, acid-buffering vaginal gel designed to regulate a woman’s vaginal pH to within the normal range of 3.5 to 4.5. This maintains an acidic environment, even after the introduction of semen during intercourse. An acidic environment is inhospitable to sperm as well as certain viral and bacterial pathogens associated with sexually transmitted infections, but it is integral to the survival of healthy bacteria in the vagina.
Evofem recently reported positive top-line results of AMPOWER, which demonstrated a 98.7% efficacy in preventing pregnancy when Amphora was used per study protocol and an 86.0% efficacy with typical use. Evofem expects to re-submit the Amphora New Drug Application (NDA) to the FDA in the second quarter of 2019. Following anticipated FDA approval by the end of 2019, expects to launch Amphora for contraception in the United States in January 2020.
When looking at the contraceptive landscape, there has been minimal true innovation since the introduction of NuvaRing in 2001. Further, innovation over the last ten years has centered around low-dose hormonal oral contraceptives, leaving the non-hormonal contraceptive market lacking. Evofem believes Amphora is an appropriate birth control option for many of the 16.5 million women in the United States who are not using any form of birth control but do not wish to get pregnant. A portion of these 16.5 million women have given up on hormonal birth control due to side effects including mood swings, weight gain, acne, and loss of libido. Per the National Center for Health Statistics, two-thirds of women cited side effects as the reason they discontinued hormonal methods.
We believe that women who want to avoid hormones and who prioritize healthy living, or who find the side effects of hormonal methods unbearable are going to be very attracted to a more natural birth control option such as Amphora.
In addition to providing a novel non-hormonal birth control option, Amphora’s vaginal pH-regulating properties may also be useful in reducing the transmission of certain STIs including chlamydia and gonorrhea.
The CDC reported in August 2018 that rates of syphilis, gonorrhea, and chlamydia climbed for the fourth consecutive year in the United States. Nearly 2.3 million U.S. cases of these STIs were diagnosed in 2017, an increase of over 200,000 cases over the prior year. Untreated, these conditions present considerable co-morbidity in both the developed and developing world. Untreated, chlamydia and gonorrhea can both lead to pelvic inflammatory disease, which can result in long term pelvic/abdominal pain, infertility, and have also been linked to ectopic pregnancy.
Evofem is actively enrolling patients in a double-blinded placebo-controlled Phase 2b clinical trial (AMPREVENCE) to evaluate Amphora for the prevention of urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. This clinical trial is enrolling 844 women at approximately 50 centers in the United States for a four-month interventional period and subsequent one-month follow-up period.
If approved, Amphora would be an important addition to the contraceptive method mix as a novel non-hormonal, woman-controlled birth control option for women. The potential “add-on” indication of Amphora for the prevention of certain STIs could establish Amphora as a lead MPT in this category.
To learn more on Amphora and the work Evofem is doing to revolutionize women’s health care, go to www.evofem.com.
Evofem Bioscienecs (NASDAQ: EVFM) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem LinkedIn and Twitter.