SAN DIEGO, May 12, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today announced that the U.S.
Food and Drug Administration (FDA) has granted Fast Track
designation for EVO100 for the prevention of urogenital gonorrhea
in women. Fast Track designation is designed to facilitate the
development and expedite the review of new therapies to treat
serious conditions and fill unmet medical needs.
According to a new report published by the Centers for Disease
Control and Prevention, more than 600,000 cases of gonorrhea were
reported in 2019, representing an increase for the sixth
consecutive year.1 Currently, there are no FDA-approved
prescription products to prevent gonorrhea.
"We are pleased that the FDA has recognized the need for a
product such as EVO100 to prevent this common STI, which is
increasingly antibiotic-resistant," said Dr. Kelly Culwell, Evofem's Chief Medical Officer.
"There are 78 million sexually active woman in the U.S. potentially
at risk of contracting sexually transmitted infections, including
gonorrhea.2 Should EVO100 receive FDA approval as a
preventive measure, this would be a welcome addition to the
physician's armamentarium in the fight against this growing public
health concern."
EVO100 previously received Fast Track designation from the FDA
for the prevention of chlamydia in women and was also designated as
a Qualified Infectious Disease Product (QIDP) by the FDA for the
prevention of gonorrhea in women. A drug that receives QIDP
designation may qualify for an additional five years of
marketing exclusivity.
Evofem's pivotal Phase 3 clinical trial of EVO100 for prevention
of chlamydia and gonorrhea in women, EVOGUARD, is currently
enrolling 1,730 women in U.S. study sites. The Company
expects to complete enrollment by year-end 2021 and to report
top-line data in mid-2022. Positive outcomes could support
submission of a New Drug Application to the FDA for these potential
indications by the end of 2022, with an anticipated PDUFA date in
the third quarter of 2023 due to the expedited review afforded by
the Fast Track designation.
EVOGUARD builds on the positive, statistically significant
results of the Phase 2B/3 AMPREVENCE
trial. This double-blinded, placebo-controlled study of EVO100 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 highly
respected American Journal of Obstetrics and
Gynecology (AJOG).
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 launched its first FDA-approved commercial product,
Phexxi® (lactic acid, citric acid and potassium
bitartrate) contraceptive vaginal gel, in the United
States in September 2020. For more information, please
visit www.evofem.com.
Phexxi® is a trademark of Evofem
Biosciences.
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, the progress and prospects of the continued development
of EVO100, included any potential timelines or evaluations of
enrollment progress, the potential need or demand for EVO100,
statements and evaluations regarding or implying potential market
acceptance and patient attitudes. 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 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. This press release contains estimates and other statistical
data made by independent parties and by the Company relating to
market size and growth and other data about its industry. This data
involves a number of assumptions and limitations, and you are
cautioned not to give undue weight to such estimates.
References
- Centers for Disease Control and Prevention. Sexually
Transmitted Disease Surveillance 2019. Atlanta: U.S. Department of Health and Human
Services; 2021. Available at
https://www.cdc.gov/std/statistics/2019/default.htm
- Based on US Census Projections, CDC Data Brief 327,
available at
https://www.cdc.gov/nchs/data/databriefs/db327_tables-508.pdf
Investor Relations
Contact
Amy
Raskopf
araskopf@evofem.com
Mobile: (917)
673-5775
|
Media
Contact
Ellen Thomas
ethomas@evofem.com
Mobile: (718) 490-3248
|
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SOURCE Evofem Biosciences, Inc.