SAN DIEGO, Sept. 8, 2020 /PRNewswire/ -- Evofem Biosciences,
Inc. (NASDAQ: EVFM) today announced that
Phexxi™ (lactic acid, citric acid and potassium
bitartrate), the first and only non-hormonal prescription vaginal
gel is now available in the United
States for the prevention of pregnancy in females of
reproductive potential for use as an on-demand method of
contraception.
Approved by the U.S. Food and Drug Administration (FDA) on
May 22, 2020, Phexxi is a vaginal pH
modulator designed to maintain vaginal pH within the normal range
of 3.5 to 4.5 – an acidic environment that is inhospitable to
sperm. Phexxi will be commercially available in a box containing 12
individually wrapped Phexxi applicators. For more information,
visit www.phexxi.com.
"As a leader of innovation in women's healthcare, we are
thrilled to usher in a new era of sexual and reproductive health
with the launch of Phexxi," said Saundra Pelletier, Evofem Biosciences' Chief
Executive Officer. "Millions of women have either settled for
less or completely opted out of using birth control because they
have had enough with side effects and lack of control. Today, we
are fulfilling Evofem's mission of delivering a novel contraceptive
option that women have been waiting for."
Evofem is also launching the Phexxi Concierge Experience, a
comprehensive woman-centric telemedicine support system to help
ensure Phexxi is accessible to all women who need it. This robust
offering of services is designed to help women quickly consult with
a healthcare provider to secure a Phexxi prescription, determine
their insurance coverage and/or out-of-pocket costs, receive
counseling support and refill reminders, and fill their
prescription through their local neighborhood pharmacy or our mail
order pharmacy partner, KnippeRx, that is expected to deliver
Phexxi right to their door.
Evofem is committed to facilitating access to Phexxi for women
who are not covered by government or private health plans and will
provide a financial assistance program to enable access to Phexxi
for eligible women. Through this program, eligible patients may pay
a $0 co-pay for their first
prescription of Phexxi, and as little as $30 on future prescriptions.
ABOUT PHEXXI™ (lactic acid, citric acid and potassium
bitartrate) VAGINAL GEL 1.8%, 1%, 0.4%
Phexxi is a
prescription vaginal gel used to prevent pregnancy in females who
choose to use an on-demand method of birth control.
LIMITATIONS OF USE
Phexxi is not effective for the
prevention of pregnancy when administered after intercourse.
IMPORTANT SAFETY INFORMATION
What are the possible
side effects of Phexxi?
There have been a few cases of
urinary bladder infection and kidney infection reported in clinical
studies. One of the cases was serious. Avoid Phexxi if you have had
repeated urinary tract infections or other urinary tract
problems.
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.
Full Prescribing Information for Phexxi is available at
Phexxi.com.
To report SUSPECTED ADVERSE REACTIONS, contact Evofem at
toll-free phone 1-833-EVFMBIO or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
About Evofem Biosciences, Inc.
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 Phase 3 clinical trials for the prevention of
urogenital transmission of both Chlamydia
trachomatis infection (chlamydia) and Neisseria
gonorrhoeae infection (gonorrhea) 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 Evofem's expectations regarding
the success of the commercial launch of Phexxi, the success of the
Phexxi Concierge Experience, our ability to obtain coverage
under the ACA and the copay assistance program. 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.
Media Contact
Becky Vonsiatsky
W2O
Bvonsiatsky@w2ogroup.com
Mobile: (413) 478-2003
Investor Relations Contact
Amy
Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Office: (858) 550-1900 x167
Mobile: (917) 673-5775
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SOURCE Evofem Biosciences, Inc.