SAN DIEGO, Oct. 7, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) announced today that new clinical
trial data on Phexxi™ (lactic acid, citric acid and potassium
bitartrate) and EVO100 are being discussed in oral and poster
presentations at major medical society meetings this month.
"We are thrilled to continue to share critical data in nine
abstracts at the key women's and reproductive health medical
society meetings this fall," said Brandi
Howard, PhD, Head of Medical Affairs at Evofem Biosciences.
"The data are part of our robust publication strategy and include
new insight into the demographics/characteristics of Phexxi users;
factors affecting chlamydia and gonorrhea reinfection rates; and
exploratory findings related to impact on sex life among women
treated with Phexxi and EVO100 in the AMPOWER and AMPREVENCE
trials, respectively."
The posters, abstracts and related publications will be made
available in the Posters and Publications section of the
company's website at www.evofem.com.
Presentation details are as follows:
Society for Family
Planning (SFP) Annual Meeting 2020
|
Dates:
|
October 9-10,
2020
|
Poster
Titles:
|
|
-
|
Impact of product
adherence and condom use on rates of urogenital re-infection with
Chlamydia trachomatis or Neisseria gonorrhoeae in the
AMPREVENCE phase 2b/3 clinical trial (Poster # 41)
|
-
|
Characterization of
women according to pregnancy status following treatment with VPR
during the AMPOWER study (Poster # 71)
|
SFP abstracts will be
published in the October 2020 issue of
Contraception.
|
|
|
Nurse
Practitioners in Women's Health (NPWH) 23rd Annual
Women's Healthcare Conference
|
Dates:
|
October 15-18,
2020
|
Poster
Title:
|
A Comparison of Women
Who Completed or Discontinued the AMPOWER Study, a Phase 3
Contraceptive Trial for Vaginal pH Regulator (Poster:
P-284)
|
|
|
American Society
for Reproductive Medicine (ASRM) 2020 Scientific
Congress
|
Oral
Presentation
|
Date:
|
Saturday, October 17,
2020
|
Time:
|
11:10 a.m.
ET
|
Title:
|
Sexual Satisfaction
with a Vaginal pH Regulator (EVO100): Results from the AMPREVENCE
Clinical Trial (Oral: 30)
|
|
|
Poster
|
|
Date:
|
Saturday, October 17,
2020
|
Time:
|
4:30 – 6:00 p.m.
ET
|
Title:
|
Characterization of
Women According to their Sexual Satisfaction After Treatment with
the Novel Vaginal pH Regulator (VPR™) During the AMPOWER Study
(Poster: P-160)
|
ASRM abstracts will
be published in the October 2020 issue of Fertility and
Sterility.
|
|
|
ACOG 2020 Virtual
Conference
|
Dates:
|
October 30-31,
2020
|
Poster
Titles:
|
|
-
|
Sexual Satisfaction
with Vaginal pH Regulator: Results from the AMPOWER Clinical
Trial
|
-
|
Perfect–Use Pregnancy
Rates with Vaginal pH Regulator: Efficacy Results from
AMPOWER
|
-
|
Genitourinary Side
Effects with Vaginal pH Regulator: Results from AMPOWER
|
ACOG abstracts were
published in the May 2020 issue of Obstetrics &
Gynecology (The Green Journal) (May 2020,
Vol 135).
|
In September, pivotal results from Evofem's
Phase 2b AMPREVENCE trial were presented at the 2020
STD Prevention Virtual Conference in a poster titled "Efficacy
and safety of a novel vaginal pH modulator for prevention of
chlamydia and gonorrhea." The biennial conference was organized by
the U.S. Centers for Disease Control and Prevention (CDC) and the
National Coalition of STD Directors.
About the AMPREVENCE Trial
AMPREVENCE was a
double-blinded, placebo-controlled Phase 2b clinical
trial that enrolled 860 women who had been treated for chlamydia or
gonorrhea in the four months prior to enrolling in the study.
Subjects were randomized to receive either EVO100 vaginal gel or
placebo vaginal gel. During the four months the women participated
in the study, they were asked to apply the product candidate or
placebo prior to each act of vaginal sexual intercourse. The
primary and secondary endpoints of the study were the reduction in
the incidence of urogenital Chlamydia
trachomatis and Neisseria gonorrhea, respectively. Fifty
centers in the United States
participated in this unprecedented trial.
About the AMPOWER Trial
AMPOWER was a single-arm,
open-label Phase 3 study designed to evaluate the efficacy and
safety of Phexxi™ (lactic acid, citric acid and potassium
bitartrate) 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 evaluate the
effects of a contraceptive product candidate on the impact of
women's sex lives (exploratory endpoint).
IMPORTANT SAFETY INFORMATION
WHAT ARE THE POSSIBLE SIDE EFFECTS OF PHEXXI™
(lactic acid, citric acid, and potassium bitartrate) vaginal gel
1.8%, 1%, 0.4%?
If you have had a history of repeated
urinary tract infections or other urinary tract problems, avoid
Phexxi™.
The most common side effects were vaginal
burning, vaginal itching, vaginal yeast infection, urinary tract
infection, vaginal area discomfort, bacterial vaginosis, and
vaginal discharge. Women also reported genital discomfort, pain
while urinating, and vaginal pain. Some male partners reported
genital discomfort.
WHAT ELSE SHOULD I KNOW ABOUT USING
PHEXXI™?
Phexxi™ does not
protect against any sexually transmitted diseases, including HIV.
Avoid using Phexxi™ with a vaginal ring.
Contact your healthcare provider if you are experiencing severe
genital irritation or discomfort or urinary tract symptoms. Avoid
Phexxi™ if you or your sexual partner is allergic
to lactic acid, citric acid, potassium bitartrate, or any of the
ingredients in Phexxi™. Stop using
Phexxi™ if you develop an allergic reaction.
Please see full Prescribing
Information for Phexxi™,
including Patient Information.
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.
WHAT IS
PHEXXI™?
Phexxi™ is a
prescription vaginal gel used to prevent pregnancy in females who
choose to use an on-demand method of birth control.
Phexxi™ is only effective when used
immediately before (or up to one hour before) each
act of vaginal sex. Phexxi™ is not effective when
used after vaginal sex.
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's first commercial product, Phexxi™ (lactic acid, citric
acid and potassium bitartrate), is the first and only hormone-free,
prescription vaginal gel approved in the United
States for the prevention of pregnancy. The Company is also
advancing EVO100 into a Phase 3 clinical trial for the
prevention of urogenital transmission of both Chlamydia
trachomatis and Neisseria gonorrhoeae in
women. For more information, please
visit www.evofem.com.
Phexxi™ is a trademark of Evofem Biosciences, Inc.
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, including, without
limitation, statements related to the planned clinical trial of
EVO100 for prevention of Chlamydia
trachomatis and Neisseria gonorrhoeae in
women. 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 filed with the SEC
on May 6, 2020 and August 4, 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.
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.