SAN DIEGO, May 22, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S. Food
and Drug Administration (FDA) has approved Phexxi™
(lactic acid, citric acid and potassium bitartrate) vaginal gel for
the prevention of pregnancy in females of reproductive potential
for use as an on-demand method of contraception.
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.
"There have been a limited number of advances in birth control
over the last two decades; Phexxi represents an important step
forward in women's health," said Michael A.
Thomas, M.D., Chair of the Department of Obstetrics and
Gynecology at the University of
Cincinnati College of Medicine. "Many of my
patients have cycled through numerous contraceptive options
and still have not found the right fit for their sexual and
reproductive needs. Phexxi offers women freedom from hormones and
control over how they choose to prevent pregnancy. I look forward
to offering this new on-demand option to my patients."
The Company expects to launch Phexxi in early September
alongside the Phexxi Concierge Experience, a comprehensive patient
and healthcare provider telemedicine support system. This robust
offering of services is designed to provide physicians with
on-demand educational support, and speed and simplify women's
access to Phexxi. Through this offering, women would be able to
secure a 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 an online pharmacy that is expected to
deliver Phexxi right to their door.
"The FDA approval of Phexxi means women now have access to a
non-hormonal contraceptive option that they control, on
their terms, to be used ONLY when they need it," said
Saundra Pelletier, Evofem
Biosciences' Chief Executive Officer. "Empowerment results from
innovation and we are proud and excited to deliver new innovation
to women in a category ready for change."
As the first vaginal pH regulator with a unique mechanism of
action, the Company is working to have Phexxi covered under the
Affordable Care Act (ACA). The ACA mandates that private health
plans provide coverage with no out-of-pocket costs for one
treatment per class in each of the classes identified by the FDA
for women in its Birth Control Guide.
Evofem is committed to ensuring access to Phexxi for all women
seeking non-hormonal contraception, including for women who are not
covered by government or private health plans, and will provide a
financial assistance program to enable access for eligible
women.
"During my 15-year career at the FDA, I participated in the
review and approval of many sexual and reproductive health
products, and I believe that Phexxi serves a true unmet need in
contraception," said Lisa Rarick,
M.D., former FDA Division Director and Evofem board member. "Phexxi
offers women protection and control—on their terms, and at their
discretion—without the use of hormones. I am proud to be a
part of this team and this moment in history."
Conference Call Details
Evofem Biosciences will host
a conference call and audio webcast to discuss the FDA approval of
Phexxi as follows:
Date
|
Tuesday, May 26,
2020
|
Time
|
8:30 a.m. EDT (5:30
a.m. PDT)
|
Dial-in
numbers
|
(866) 503-5561
(U.S. toll-free) or (253) 336-2965
|
Passcode
|
4638796
|
Webcast
|
www.evofem.com under "Investors" or click
here
|
Please connect to the Company's website at least 15 minutes
prior to the start of the call to download any software that may be
required. If participating by phone, please dial in
approximately 10 minutes prior to the start of the call.
A telephone replay will be available approximately two hours
after the call through Sunday May 30, 2020, at (855) 859-2056
(U.S.) or (404) 537-3406, access code 4638796. The live and
archived webcast can be accessed at
https://evofem.investorroom.com/events.
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%) of 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.
ADVERSE REACTIONS
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 their healthcare provider for severe
or prolonged genital irritation or experiencing urinary tract
symptoms.
- To discontinue Phexxi if they develop a local
hypersensitivity reaction.
- That Phexxi does not protect against HIV infection or other
sexually transmitted infections.
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 www.fda.gov/medwatch.
Full Prescribing Information for Phexxi is available at
Phexxi.com.
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. Evofem Biosciences aims to
advance the lives of women by developing innovative solutions, such
as woman-controlled contraception and potential protection from
certain sexually transmitted infections (STIs). The Company's first
commercial product, Phexxi™ (lactic acid, citric acid and potassium
bitartrate), is approved in the United
States for the prevention of pregnancy. The Company is
advancing EVO100 for the prevention of urogenital transmission of
both Chlamydia trachomatis infection (chlamydia)
and Neisseria gonorrhoeae infection (gonorrhea) in
women. For more information regarding Evofem, please
visit www.evofem.com.
Forward-Looking Statements
This press release
contains "forward-looking statements" within the meaning of the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including statements related to Evofem Biosciences'
expectations regarding the success and timing of commercial launch
and availability of Phexxi, the availability and success of our
telehealth support system and our ability to obtain coverage under
the ACA. Each of these forward-looking statements involves risks
and uncertainties. Actual results may differ materially from those,
express or implied, in these forward-looking statements. Important
factors that could impair the value of Evofem Biosciences' assets
and business are disclosed in the risk factors contained in its
Annual Report on Form 10-K, and Quarterly Report on 10-Q for the
first quarter of 2020 filed with the Securities and Exchange
Commission and subsequent filings. All forward-looking
statements are expressly qualified in their entirety by such
factors. Evofem Biosciences does not undertake any duty to update
any forward-looking statement except as required by law.
Contact
Investors
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Office: (858) 550-1900 x167
Mobile: (917) 673-5775
Media
Cara Miller
Evofem Biosciences, Inc.
Vice President, Public Affairs and Corporate Communications
cmiller@evofem.com
Office: (858) 550-1900 x272
View original content to download
multimedia:http://www.prnewswire.com/news-releases/us-fda-approves-evofem-biosciences-phexxi-lactic-acid-citric-acid-and-potassium-bitartrate-the-first-and-only-non-hormonal-prescription-gel-for-the-prevention-of-pregnancy-301064469.html
SOURCE Evofem Biosciences, Inc.