SAN DIEGO, May 17, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today announced that new research
on its investigational drug EVO100 for the prevention of chlamydia
and gonorrhea in women will be highlighted in a poster presentation
at the annual meeting of the Professional Society for Health
Economics and Outcomes Research, Virtual ISPOR 2021, which will be
held May 17 to 20, 2021.
Abstract:
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108785
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Title:
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Assessing the
Understandability and Importance of Patient Reported Outcomes
Impacting Adherence and Outcomes of a Non-Hormonal Vaginal
Microbicide to Protect Against Chlamydia Trachomatis (CT) and
Neisseria Gonorrhoeae (GC)
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Authors:
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Robert Morlock, PhD;
Lalitha Aiyer, MD, MS, MBA, FAIHM; Kelly Culwell, MD, MPH, FACOG;
Brandon Howard, PhD
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Date:
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Tuesday, May 18,
2021
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Qualitative research was conducted among 21 women with previous
experience with EVO100. The study objective was to assess the
understandability and importance of questions/instruments used to
assess product and global sexual satisfaction in the Phase
2b clinical study EVO-003
(AMPREVENCE), which met its primary and secondary efficacy
endpoints with statistically significant reductions in the risk of
chlamydia and gonorrhea infections.
Participant interviews explored the concepts of sexual
satisfaction and understandability of the Female Sexual Function
Index (FSFI) global sexual satisfaction and product satisfaction
questions in AMPREVENCE. Patients were also asked about the
importance of a microbicide to protect against infection and
understanding the impact on sexual satisfaction.
Participants reported that adherence with use of EVO100 was
related to product satisfaction and the impact on global sexual
satisfaction as well as efficacy. All participants indicated that
this information was important to know for women considering a
microbicidal vaginal gel like EVO100.
Abstracts have been published in the May
2021 issue of Value in Health1, the
international journal of ISPOR. The poster is available to
registered Virtual ISPOR 2021 attendees at
https://virtualispor2021.secure-platform.com/a/organizations/main/home and
will be available following the conference at
https://www.evofem.com/posters-and-publications/.
Enrollment is underway in EVOGUARD, the pivotal Phase 3 clinical
trial of EVO100 for prevention of chlamydia and gonorrhea in women.
All 90 planned study centers have been identified and more than 80
sites have been activated. 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.
EVO100 has been granted Fast Track designation from the FDA for
the prevention of urogenital chlamydia and 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.
Additionally, the investigational drug is designated 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.
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 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. 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.
References
- Morlock R et al. Assessing the Understandability
and Importance of Patient Reported Outcomes Impacting Adherence and
Outcomes of a Non-Hormonal Vaginal Microbicide to Prevent and
Protect Against Chlamydia trachomatis (CT) and Neisseria
gonorrhoeae (GC). Value in Health, Volume
24, Issue 5, S1 (May 2021)
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.