SAN DIEGO, April 24, 2020 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that three new data sets from the Company's Phase 3 AMPOWER trial evaluating Phexxi™, a first-in-class investigational Multipurpose Vaginal pH Regulator (MVP-R™) for the prevention of pregnancy, were accepted for poster presentations at the 2020 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting and published in the esteemed journal, Obstetrics & Gynecology (The Green Journal).
"These data not only demonstrate the high efficacy rates of more than 93% when Phexxi is used as directed, they also underscore the sexual satisfaction and lubricating factors experienced by women in the AMPOWER trial – something no other contraceptive trial has reported," said Saundra Pelletier, Chief Executive Officer of Evofem Biosciences. "We remain on track for our May 25, 2020 regulatory action date and, if approved, we look forward to delivering to women the first non-hormonal contraceptive innovation in decades."
While the in-person 2020 meeting was cancelled due to COVID-19 concerns, ACOG is exploring virtual options to showcase scientific and educational highlights from the meeting. In the interim, key highlights from the ACOG abstracts follow. Additional presentations and publications from the AMPOWER data are planned for the second half of 2020.
Perfect-Use Pregnancy Rates with Vaginal pH Regulator: Efficacy Results from AMPOWER
B. Todd Chappell, M.D., Adams Patterson Gynecology & Obstetrics, Women's Care Center of Memphis
In this new subset analysis of 1,003 women evaluable for efficacy in the AMPOWER trial, perfect-use pregnancy rates were reported for seven cycles of Phexxi use. Multiple sensitivity analyses were performed to remove confounding factors and more accurately evaluate the efficacy of Phexxi when used as directed.
- Expanding cycle lengths to include 21 to 42-day cycles;
- Removing subjects with incomplete washout of previous hormonal contraceptive; and
- Removing pregnancies from cycles with inconsistent eDiary reporting in which no sexual activity with product use was reported ± 7 days from the estimated date of conception.
Results demonstrate that perfect-use pregnancy rates following seven cycles of Phexxi ranged from 9.99% to 6.67%, or 90.0% to 93.3% efficacy.
Sexual Satisfaction with Vaginal pH Regulator: Results from the AMPOWER Clinical Trial
Michael A. Thomas, M.D., University of Cincinnati
AMPOWER is the only large-scale, Phase 3 contraceptive clinical trial to explore the effects of a contraceptive product candidate on sexual satisfaction. Based on questionnaires administered at baseline and at study visits 3, 4 and 5, more women reported positive impact on their sex lives with Phexxi compared to their previous method of birth control. At baseline, just 17% of study participants reported their most recent contraception made their sex life 'a little' or 'a lot' better than before. However, after at least one cycle of Phexxi use, 45% of women reported their sex life was 'a little' or 'a lot' better. Women also reported an increase in their ability to maintain lubrication during intercourse (82.5% at visit three versus 73.9% at baseline).
Genitourinary Side Effects with Vaginal pH Regulator: Results from AMPOWER
Bassem Maximos, M.D., M.P.H., Maximos Ob/Gyn, League City, Texas
Among the 1,330 women included in the AMPOWER safety analysis, the most common adverse events (>10%) were vaginal burning and itching. Results demonstrate that the reported rates of vaginal burning and itching decreased with each consecutive cycle (up to 7 cycles) from 20% to 1.4% and 11.2% to 0.3%, respectively.
Among those who experienced side effects, rates were highest among the 77 women who reported genitourinary (GU) side effects while on study. Overall, the rate of study discontinuation due to GU symptoms was less than 1% (n=13/1330).
The Phase 3 AMPOWER clinical trial was designed to assess the efficacy and safety of the investigational contraceptive candidate Phexxi among approximately 1,330 women enrolled at 112 centers in the United States. Phexxi met the pre-specified primary endpoint of this trial, had a favorable safety profile, and was well tolerated.
Phexxi (L-lactic acid, citric acid, potassium bitartrate) Vaginal Gel 1.8%/1%/0.4% is an investigational Multipurpose Vaginal pH Regulator (MVP-R™) designed to regulate vaginal pH within the normal range of 3.5 to 4.5, even in the presence of semen, which normally raises the vaginal pH to 7.0 to 8.0. This maintains an acidic environment that is inhospitable to sperm, as well as certain viral and bacterial pathogens associated with sexually transmitted infections, but is integral to the survival of healthy bacteria in the vagina.
About Evofem Biosciences, Inc.
Evofem Biosciences, Inc., (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 Biosciences aims to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs). The Company's lead product candidate, Phexxi™, is currently being reviewed by the U.S. Food and Drug Administration for prevention of pregnancy. The investigational candidate EVO100 is being evaluated for prevention of urogenital transmission of both Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women. For more information regarding Evofem, please visit www.evofem.com.
Phexxi™ and Multipurpose Vaginal pH Regulator (MVP-R™) are trademarks of Evofem Biosciences, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements other than historical facts and often address future events or the future performance of the Company. All forward-looking statements reflect management's present expectations regarding future events and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by any forward-looking statements. These risks, uncertainties and other factors include, among others: risks relating to the Company's business and general industry, economic, political and market conditions that may impact its market capitalization, including the impact of the novel coronavirus (COVID-19), and the surrounding duration and severity of an outbreak, and risks associated with litigation. These and other risks and uncertainties are described in the Company's annual report on Form 10-K filed on March 12, 2020, and subsequent filings with the U.S. Securities and Exchange Commission it makes from time to time. Given these risks, uncertainties and other important factors, undue reliance should not be placed on these forward-looking statements. These forward-looking statements represent the Company's estimates and assumptions only as of the date made, and except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements for any reason.
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