SAN DIEGO, April 28, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today announced that two new data
sets from its Phase 3 AMPOWER trial evaluating
Phexxi® (lactic acid, citric acid, potassium
bitartrate) will be presented at the 2021 American
College of Obstetricians and Gynecologists (ACOG) Annual Clinical
and Scientific Meeting (ACSM). The meeting will be conducted
virtually from April 30 - May 2,
2021.
"These new data sets provide clinical insights into how women
used Phexxi in the AMPOWER clinical trial as well as their feelings
about pregnancy, which are both important factors for clinicians to
consider when counseling and prescribing Phexxi," said Brandi
Howard, PhD, Head of Medical Affairs at Evofem
Biosciences.
Both posters will be available to meeting attendees on the ACOG
website at https://www.acog.org beginning April 30, 2021, and will be made available
in the Posters and Publications section of the company's
website at www.evofem.com.
Additionally, the role of vaginal pH modulators in contraception
and the contributions of current contraceptive trial design on the
"creeping Pearl Index" will be discussed in a Continuing Medical
Education (CME) course offered to ASCM attendees. The event is
sponsored by an unrestricted educational grant from Evofem
Biosciences.
Title:
|
A New Nonhormonal
Contraceptive Choice: The Vaginal pH Modulator
|
Presenters:
|
David L. Eisenberg,
MD, MPH, FACOG; Patty Cason, RN, MS FNP-C; and David J. Portman,
MD
|
Live event:
|
Wednesday April 28,
2021 from 8:00-9:30pm ET (virtual broadcast)
|
ACOG Abstracts Highlights
Compliance with Vaginal
pH Modulator in the Phase 3 AMPOWER Contraceptive Trial
David L. Eisenberg, MD, MPH,
FACOG ; Kelly Culwell, MD, MPH;
Clint Dart, MS; Brandon Howard, PhD
In AMPOWER, compliance with use was defined as administration of
Phexxi intravaginally less than or equal to 1 hour before each
episode of intercourse, re-application with additional acts of
intercourse, and no use of an additional contraceptive method.
Women completed daily e-Diaries to record Phexxi use and coital
information. Compliance was calculated based on the percentage of
total coital acts reported by each woman throughout the duration of
her enrollment in the study.
Of the 1384 women enrolled in AMPOWER, 1330 women reported one
or more use of Phexxi and 1255 women recorded one or more coital
act. Of 32,680 total acts of intercourse, Phexxi was used correctly
and as the only contraceptive method, per the study protocol, 84%
of the time.
Pregnancy Intendedness with Vaginal pH Modulator: Results
From the Phase 3 AMPOWER Trial
Bassem Maximos, MD, MPH; Kelly Culwell, MD, MPH; Clint Dart, MS; Brandon
Howard, PhD
Pregnancy intendedness was an exploratory endpoint in AMPOWER.
Questionnaires were given at baseline and at subsequent study
visits to assess, using a 10-point Likert scale, how participants
would feel if they became pregnant. Additional sensitivity analyses
investigated correlations between pregnancy intendedness and
women's demographic and obstetric history.
Throughout the study, women who completed the questionnaires
(1182 of 1384 women enrolled) reported a wide range of feelings
about pregnancy, suggesting that efficacy may not always be the
most important characteristic with contraceptive use, even when
enrolled in a contraceptive clinical trial.
About AMPOWER
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 include an exploratory endpoint to evaluate the
effects of a contraceptive product candidate on women's sex
lives.
About Evofem Biosciences
Evofem Biosciences,
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 launched its first FDA-approved commercial
product, Phexxi® contraceptive vaginal gel, in
the United States in September 2020. The Company's lead
product candidate, EVO100, is being evaluated for the prevention of urogenital Chlamydia trachomatis and
Neisseria gonorrhoeae infection in women in the
ongoing Phase 3 clinical trial, 'EVOGUARD.' For more
information, please visit www.evofem.com.
Phexxi® is a registered trademark of
Evofem Biosciences, Inc.
About PHEXXI®
Phexxi® is an
on-demand method of birth control used to prevent pregnancy.
Phexxi® is not
effective when used after sex.
IMPORTANT SAFETY INFORMATION
- Rare cases (0.36%) of bladder and kidney infection 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 any sexually
transmitted infections, including HIV.
For more information about Phexxi®, talk to your
healthcare provider and see full Product Information, which is
available at
https://www.phexxi.com/themes/custom/phexxiDTC/dist/pdf/PhexxiUSPI.pdf.
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.
Forward-Looking Statements
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. 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, 2020 filed with
the SEC on March 4, 2021. 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.
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
Media Contact
Ellen
Thomas
Evofem Biosciences, Inc.
ethomas@evofem.com
Mobile: (718) 490 -3248
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SOURCE Evofem Biosciences, Inc.