• 
  Throughout 24,289 Acts of Intercourse, 101 Pregnancies were Reported with Typical Use of Phexxi in AMPOWER
  
  Post Hoc
  
  Analysis
  

SAN DIEGO


,


June 16, 2022


/PRNewswire/ —

Evofem Biosciences, Inc.,

(Nasdaq: EVFM) today announced results of a

post hoc

analysis of the registrational Phase 3 AMPOWER trial investigating the ability of Phexxi

^®

(lactic acid, citric acid, and potassium bitartrate) to prevent pregnancy.

In the analysis, Phexxi prevented 99% of pregnancies per act of intercourse. This was based on 101 pregnancies (n=1182) over 24,289 acts of intercourse with typical use in 1,182 women. The per-act-of-intercourse pregnancy risk of 0.415% was not statistically tested in AMPOWER and, therefore, is not in the U.S. Prescribing Information (USPI) approved by the FDA.

“Providing data showing how Phexxi performs on-demand to prevent pregnancy per act of intercourse helps women and their doctors better understand Phexxi and the value its innovation adds to the armamentarium of choice,” said

Saundra Pelletier

, Chief Executive Officer of Evofem.

Earlier this year, the

Journal of Sexual Medicine

published a

post hoc

analysis of an exploratory endpoint showing that 88.7% of women using Phexxi in AMPOWER improved or maintained their sex life.  Additionally, last month, Evofem presented a

post hoc

analyses at the American College of Obstetricians and Gynecologists annual clinical and scientific meeting showing that incidences of urinary tract infections in women who used Phexxi in AMPOWER were less compared to the general population (5.8% vs 11.0%, respectively).

The FDA approved Phexxi in May of 2020 based on the registrational AMPOWER trial, which enrolled 1,349 women in the U.S., as well as combined safety data from AMPOWER and a previous Phase 3 trial, AMP-001, which together provided more than 19,000 cycles of exposure in 2,804 women from the U.S. In AMPOWER, Phexxi demonstrated contraceptive efficacy, with a 7-cycle cumulative pregnancy rate of 13.7% (95% CI: 10.0%, 17.5%) with typical use and 6.67% with perfect use (95% CI: 4.61%, 8.73%), corresponding to an efficacy rate of 86.3% and 93.3%, respectively, in preventing pregnancy. Evofem has not studied Phexxi’s efficacy and safety in comparison to other contraceptives.

Phexxi’s mechanism of action through vaginal pH modulation results in the immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. Phexxi is not a spermicide and does not contain surfactants such as nonoxynol-9, which causes irreversible membrane alterations of the sperm cells thereby damaging the sperm cell membranes and killing the sperm cells.

^i,ii

Phexxi is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex.

• Rare cases (0.36%) of bladder and kidney infections have been reported. If you have a history of urinary tract problems that keep coming back, you should not use Phexxi.
• Contact your healthcare provider if you are experiencing genitourinary side effects such as vaginal burning, itching, discharge, genital discomfort (including in male partners), yeast infection, urinary tract infection or bacterial vaginosis.
• Phexxi does not protect against sexually transmitted infections, including HIV.

For more information about Phexxi, talk to your healthcare provide and see full Product Information at

www.phexxi.com

.

Please report side effects by contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch

.

Intended for United States residents only.

Evofem Biosciences, Inc., (Nasdaq: EVFM) is developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from chlamydia and gonorrhea. The Company’s first FDA-approved product, Phexxi

^®

(lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at

phexxi.com

and

evofem.com

.

Phexxi

^®

is a registered trademark of Evofem Biosciences, Inc.

This press release includes “forward-looking statements,” within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to timing and outcome of the registrational Phase 3 EVOGUARD trial and any submission or approval of Phexxi to or by the FDA for the prevention of chlamydia and gonorrhea. Various factors could cause actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements, or that could impair the value of Evofem Biosciences’ assets and business, are disclosed in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 10, 2022. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Media Contact



Jack Hirschfield


Evofem Biosciences, Inc.


[email protected]


(512) 674-5163

Investor Relations Contact



Amy Raskopf


Evofem Biosciences, Inc.


[email protected]


(917) 673-5775

ⁱ

Schill WB et al. Ultrastructure of human spermatozoa in the presence of the spermicide nonoxynol-9 and a vaginal contraceptive containing nonoxynol-9. Andrologia 1981; 13:42–9.

ⁱⁱ

Grimes et al. Spermicide Used Alone for Contraception. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD005218

View original content to download multimedia:

https://www.prnewswire.com/news-releases/phexxi-prevented-99-of-pregnancies-per-act-of-intercourse-in-a-post-hoc-analysis-of-phase-3-ampower-clinical-trial-data-301569515.html

SOURCE Evofem Biosciences, Inc.