SAN DIEGO, Nov. 30, 2021 /PRNewswire/ -- Evofem Biosciences,
Inc. (NASDAQ: EVFM) today reported a successful Type C meeting with
the U.S. Food and Drug Administration in which agreement was
reached on the preliminary submission strategy for EVO100 for two
investigational indications: the prevention of urogenital chlamydia
in women and the prevention of urogenital gonorrhea in women.
There are currently no FDA-approved prescription products to
prevent either of these sexually transmitted infections (STIs).
Chlamydia and gonorrhea are the two most frequently reported
bacterial STIs in the United
States. More than 1.8 million cases of chlamydia and 600,000
cases of gonorrhea were reported in 2019, representing an increase
for the sixth consecutive year.1 However, because
many infections are asymptomatic, reported cases only capture
a fraction of the true burden.
Evofem's pivotal Phase 3 clinical trial of EVO100 for prevention
of chlamydia and gonorrhea in women, EVOGUARD, is currently
enrolling 1,730 women at study sites across the United States.
EVOGUARD builds on the positive results of the Phase
2B/3 AMPREVENCE trial, which met its
primary and secondary efficacy endpoints with statistically
significant reductions in the risk of chlamydia and gonorrhea
infections. The pivotal AMPREVENCE manuscript was published in
March 2021 in the American Journal
of Obstetrics and Gynecology (AJOG).
EVO100 received two Fast Track designations from the FDA for the
prevention of chlamydia and prevention of gonorrhea in women. Fast
Track is designed to expedite the review of new therapies to treat
serious conditions and fill unmet medical needs. EVO100 is also
designated a Qualified Infectious Disease Product by the FDA for
the prevention of urogenital gonorrhea infection in women, which
may provide an additional five years of marketing exclusivity.
The Company expects to report top-line EVOGUARD data in the
second half of 2022. Positive outcomes could support submission to
the FDA for these potential indications in the first quarter of
2023, with an anticipated PDUFA date in the second half of 2023 due
to the expedited review afforded by the Fast Track
designations.
"We are pleased that the FDA has recognized the unmet need in
preventing these pervasive STIs and look forward to working closely
with the Agency to facilitate the review and anticipated approval
of what we believe will be the first product approved for the
prevention of chlamydia and gonorrhea, as well as hormone-free
contraception, in the United
States," said Saundra
Pelletier, CEO of Evofem Biosciences.
1 US Centers for Disease Control and
Prevention – National Overview – Sexually Transmitted Disease
Surveillance (2019)
About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) is developing and
commercializing innovative products and product candidates to
address unmet needs in women's sexual and reproductive health,
including hormone-free, woman-controlled contraception and
protection from certain sexually transmitted infections (chlamydia
and gonorrhea). The Company's first FDA-approved product, Phexxi®
(lactic acid, citric acid and potassium bitartrate), is
a hormone-free, on-demand prescription contraceptive vaginal
gel. It comes in a box of 12 pre-filled applicators and is applied
0-60 minutes before each act of sex. Learn more at phexxi.com
and evofem.com.
Phexxi® is a registered 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 timing and
outcome of the pivotal Phase 3 trial and any submission or approval
of EVO100 to the FDA. Various factors could cause actual results to
differ materially from those discussed or implied in the
forward-looking statements, including market and other conditions,
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 Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
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SOURCE Evofem Biosciences, Inc.