SAN DIEGO, Feb. 9, 2022 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) announced today that the
U.S. Food and Drug Administration (FDA) has awarded "Qualified
Infectious Disease Product" (QIDP) Designation to EVO100 (the
investigational name for Phexxi® (lactic acid, citric acid and
potassium bitartrate)) for the prevention of urogenital chlamydia
infection in women, a potential new indication in late stage
clinical development. Chlamydia is the most frequently
reported bacterial infection in the United States.
Top-line data from EVOGUARD, the confirmatory Phase 3
trial of Phexxi for the prevention of chlamydia and gonorrhea, are
expected in the third quarter of 2022. Positive outcomes could
support submission to the FDA for these potential new indications
in the first quarter of 2023.
"The unmet need for STI prevention for millions of women is
significant when you consider that there are no FDA-approved
products available to prevent infection with either chlamydia or
gonorrhea," said Saundra Pelletier,
CEO of Evofem Biosciences. "Every sexually active woman, no
matter what form of contraception she is using, is potentially at
risk to contract one of these STIs, which we believe represents a
large potential new market opportunity for Evofem."
The CDC estimates that 4.0 million and 1.6 million new cases of
chlamydia and gonorrhea, respectively, occurred in 2018
alone.1 The number of reported cases is lower than
the estimated total number because infected people are often
unaware of, and do not seek treatment for, their infections. Almost
60% of women infected with chlamydia have no
symptoms.2
Chlamydia and gonorrhea have been reported to be responsible for
one-third to half of pelvic inflammatory disease (PID) cases.
PID can cause serious, long-term problems including
infertility, ectopic pregnancy, and chronic pelvic
pain.3
QIDP designation is intended to encourage development of new
drugs for the treatment of serious or life-threatening infections.
A drug or product in development that receives this
designation qualifies for an additional five years of
marketing exclusivity following FDA approval for that
indication.
The FDA previously granted EVO100 (Phexxi) Fast Track
Designation for the prevention of both chlamydia and gonorrhea, and
in 2017 awarded QIDP Designation to EVO100 (Phexxi) for the
prevention of gonorrhea in women.
Sources:
1 https://www.cdc.gov/std/infertility/default.htm#infnote1
2 Patel, Chirag G et al. "The Proportion of Young
Women Tested for Chlamydia Who Had Urogenital Symptoms in Physician
Offices." Sexually transmitted diseases vol. 45,9
(2018): e72-e74. doi:10.1097/OLQ.0000000000000858
3
https://www.acog.org/en/womens-health/faqs/pelvic-inflammatory-disease
About Evofem Biosciences
Evofem Biosciences, Inc.,
(NASDAQ: EVFM) is 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 (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
confirmatory Phase 3 trial, any submission or approval of Phexxi to
or by the FDA for the prevention of chlamydia and gonorrhea, and
the size of the market opportunity in preventing chlamydia and
gonorrhea. 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 Relations Contact
Amy
Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
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SOURCE Evofem Biosciences, Inc.