SAN DIEGO, July 15, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM), a commercial-stage
biopharmaceutical company, today announced that
Contraception, an international, peer-reviewed, reproductive
health journal, published the primary efficacy and safety results
from the Phase 3 AMPOWER study evaluating Phexxi™ (lactic
acid, citric acid and potassium bitartrate) for the prevention of
pregnancy. The results were published "online first" this week in
Contraception: X (https://bit.ly/38HLFBh) and will appear in
a future print edition of the journal.
Phexxi is the first non-hormonal, on-demand, vaginal pH
regulator contraceptive designed to maintain vaginal pH within the
normal range of 3.5 to 4.5 – an acidic environment that is
inhospitable to sperm. It was approved by the U.S. Food and Drug
Administration (FDA) on May 22, 2020
for the prevention of pregnancy in females of reproductive
potential for use as an on-demand method of contraception based on
the results of the Phase 3 AMPOWER study.
"The publication of these pivotal data in such an
important, peer-reviewed journal underscores the rigor of the
AMPOWER clinical trial and the importance of our novel approach to
addressing women's contraceptive needs," said Saundra Pelletier, Evofem Biosciences' Chief
Executive Officer. "Through the ongoing presentation and
publication of new data, we are ensuring that clinicians have the
most comprehensive information available about Phexxi, the first
and only non-hormonal prescription contraceptive gel that puts
women in full control of their sexual and reproductive health. We
look forward to the commercial launch of Phexxi in early September
and the opportunity to provide an innovative option to the more
than 17 million women in the U.S. who are fed up with hormonal
The final data analysis demonstrated a cumulative pregnancy rate
of 13.7% over seven cycles of use (95% CI 10.0, 17.5). The
incidence of serious adverse events (SAEs) was low (1.1%), and none
of the SAEs were considered definitely related to treatment with
Phexxi. Most adverse events (AEs) were mild to moderate in
severity, and fewer than 2% of treated subjects discontinued
prematurely due to an AE.
The study also measured self-reported satisfaction ratings
related to Phexxi use. At baseline, less than half (46.5%) of the
1,325 respondents were "satisfied" or "very satisfied" with their
existing contraceptive method. This number nearly doubled
during the trial, with greater than 80% of women reported
being "satisfied" or "very satisfied" with the use of Phexxi.
AMPOWER was a single-arm, open-label
Phase 3 study designed to evaluate the efficacy and safety of
Phexxi in preventing pregnancy. The study enrolled 1,384
women aged 18-35 years across 112 centers in the United States. AMPOWER is the only
large-scale, Phase 3 contraceptive clinical trial to explore the
effects of a contraceptive product candidate on the impact of
women's sex lives.
Three new data sets from the AMPOWER trial were accepted for
presentation at the 2020 American College of Obstetricians and
Gynecologists (ACOG) Annual Meeting in April and published in
Obstetrics & Gynecology (The Green
Journal). Among the key findings:
- Perfect-use failure rates over seven cycles of Phexxi ranged
from 6.67% to 9.99% .
- Data collected as part of an exploratory endpoint at baseline
and at study visits 3, 4 and 5 (after at least one cycle of Phexxi
use), demonstrated that 45% of women reported their sex life was 'a
little' or 'a lot' better compared to just 17% at baseline.
- Rates of genitourinary (GU) symptoms associated with the use of
Phexxi decreased from baseline with each consecutive cycle (up to 7
cycles) from 20% to 1.4% in women with existing GU infections and
11.2% to 0.3% in the general study population.
Additional data have been accepted and will be presented at two
major medical meetings this fall, including the Society of Family
Planning's Virtual Annual Meeting (Oct.
9-10) and the Nurse Practitioners in Women's Health
(NPWH) 23rd Annual Premier Women's Healthcare Virtual Conference
For more information, please visit the "Posters and
Publications" page on the Evofem website
About Phexxi™ (lactic acid, citric acid and potassium
bitartrate) Vaginal Gel
Phexxi is indicated for the
prevention of pregnancy in females of reproductive potential for
use as an on-demand method of contraception.
Limitations of Use
Phexxi is not effective for the
prevention of pregnancy when administered after intercourse.
Warnings and Precautions
Few cases (0.36%) reported
adverse reactions of cystitis, pyelonephritis and other upper
urinary tract infection (UTI) have been reported in Phexxi clinical
studies. Of these, one case of pyelonephritis was considered
serious and required hospitalization. Avoid use of Phexxi in
females of reproductive potential with history of recurrent urinary
tract infection or urinary tract abnormalities.
Most common adverse reactions (≥2%)
were vulvovaginal burning sensation, vulvovaginal pruritus,
vulvovaginal mycotic infection, urinary tract infection,
vulvovaginal discomfort, bacterial vaginosis, vaginal discharge,
genital discomfort, dysuria, and vulvovaginal pain.
Patients should be counseled on the following:
- To contact and consult with their healthcare provider for
severe or prolonged genital irritation or experiencing urinary
- To discontinue Phexxi if they develop a local
- That Phexxi does not protect against HIV infection (AIDS) or
other sexually transmitted infections.
Please see full Prescribing Information for Phexxi. To report
suspected adverse reactions, contact Evofem at toll-free phone
1-833-EVFMBIO or you may contact FDA at 1-800-FDA-1088 or
About Evofem Biosciences, Inc.
Inc., (NASDAQ: EVFM) is a commercial-stage biopharmaceutical
company committed to 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 certain sexually transmitted infections (STIs). The
Company's first commercial product, Phexxi™ (lactic acid, citric
acid and potassium bitartrate), is the first and only vaginal pH
regulator approved in the United
States for the prevention of pregnancy. The Company is also
advancing EVO100 into Phase 3 clinical trials for the prevention of
urogenital transmission of both Chlamydia
trachomatis infection (chlamydia) and Neisseria
gonorrhoeae infection (gonorrhea) in women.
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 Evofem's expectations. 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 Evofem's
SEC filings, including its Annual Report on Form 10-K for the year
ended December 31, 2019 filed with
the SEC on March 12, 2020, its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 6, 2020 and its Current Report on Form 8-K
filed with the SEC on June 2, 2020.
All forward-looking statements are expressly qualified in their
entirety by such factors. Evofem does not undertake any duty to
update any forward-looking statement except as required by law.
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SOURCE Evofem Biosciences, Inc.