SAN DIEGO, April 21, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today announced the company will
deliver the keynote address and present two poster presentations on
Phexxi® (lactic acid, citric acid, potassium
bitartrate) at the upcoming NCODA 2021 National Spring
Forum, which will be held April 28 to
30 as a virtual E-Meeting.
CEO Saundra Pelletier will
deliver a keynote address entitled Evofem Biosciences and NCODA
Partnering to Raise Awareness About Phexxi: Supporting the
Reproductive and Sexual Health of Women with Cancer on
Wednesday, April 28 at 12:05pm PT.
"We look forward to engaging with the NCODA membership at the
2021 National Spring Forum among other ongoing initiatives to
ensure that female cancer patients and their oncology teams are
aware that there is an FDA-approved, hormone-free, non-invasive
contraceptive available: Phexxi," said Ms. Pelletier.
Following the 2021 National Spring Forum, the National Community
Oncology Dispensing Association (NCODA) will publish a
Positive Quality Intervention (PQI) in connection with Phexxi. PQIs
are part of the NCODA Quality Standards. These resources are
designed to operationalize and standardize practices to achieve
positive outcomes for patients. The PQI will educate oncologists
and other members of the medically-integrated oncology pharmacy
team who are involved in the care of oncology patients for whom
Phexxi may be prescribed for hormone-free contraception.
Two posters on data sets from Evofem's Phase 3 AMPOWER trial
evaluating Phexxi will be presented at the
conference:
- Sexual Satisfaction with Phexxi, a Hormone-Free Vaginal
Contraceptive: Results from the AMPOWER Clinical Trial
- Perfect–Use Pregnancy Rates with Phexxi, a Non-Hormonal
Vaginal Contraceptive: Results from the Phase 3 AMPOWER
Trial
"Female cancer patients can experience interruptions in their
sex life while still maintaining a need for contraception,"
noted Brandi Howard, Ph.D., Evofem
Biosciences' Head of Medical Affairs. "These data present relevant
aspects of the AMPOWER trial that will be important for oncology
professionals and their female patients to consider as they
evaluate which hormone-free prescription contraceptive meets her
needs before, during and after her cancer treatment regimen."
The posters will be available following the conference at
https://www.evofem.com/posters-and-publications/. These data
sets were previously presented at the ACOG 2020 Virtual Conference
with abstracts published in the May
2020 issue of Obstetrics &
Gynecology (The Green Journal) (May 2020, Vol 135).
Every year in the United States, more than 800,000 new
cases of cancer are reported among women.1 Many
cancer treatment protocols require female patients of reproductive
age to use birth control while undergoing treatment. Non-hormonal
prescription contraception options are starkly limited; previously,
women were generally steered toward condoms or the copper IUD, a
prescription medical device that is implanted in the uterus where
it releases copper ions and causes inflammation.
The collaboration between NCODA and Evofem launched in
February 2021 to positively
impact the quality of life for female patients living with,
fighting and recovering from cancer by raising awareness about the
importance and availability of Phexxi as a birth control option.
They are working together to develop and share resources and
educational information for the medically-integrated oncology
pharmacy team to help support female cancer patients in
deciding which contraceptive option best meets each woman's unique,
individual needs.
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® contraceptive vaginal gel, in the United States in September 2020. The Company's lead product
candidate, EVO100, is being evaluated for the prevention of
urogenital Chlamydia trachomatis and Neisseria
gonorrhoeae infection in women in the ongoing Phase 3 clinical
trial, 'EVOGUARD.' For more information, please visit
www.evofem.com.
Phexxi® is a registered trademark of
Evofem Biosciences, Inc.
About the AMPOWER Trial
AMPOWER was a single-arm, open-label Phase 3 study designed to
evaluate the efficacy and safety of Phexxi® (lactic
acid, citric acid and potassium bitartrate) in preventing
pregnancy. The study enrolled 1,384 women aged 18-35 years
across 112 centers in the United States. AMPOWER is the
only large-scale, Phase 3 contraceptive clinical trial to evaluate
the effects of a contraceptive product candidate on the impact of
women's sex lives (exploratory endpoint).
About PHEXXI®
Phexxi® is an
on-demand method of birth control used to prevent pregnancy.
Phexxi® is not
effective when used after sex.
IMPORTANT SAFETY INFORMATION
- Rare cases (0.36%) of bladder and kidney infection have been
reported. If you have a history of urinary tract problems that keep
coming back, you should not use Phexxi®.
- Contact your healthcare provider if you are experiencing
genitourinary side effects such as vaginal burning, itching,
discharge, genital discomfort (including in male partners), yeast
infection, urinary tract infection or bacterial vaginosis.
- Phexxi® does not protect against any sexually
transmitted infections, including HIV.
For more information about Phexxi®, talk to your
healthcare provider and see full Product Information.
Please report side effects by contacting Evofem Biosciences®
toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
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.
This press release contains statistical data provided by
independent parties relating to disease incidence. This data
involves a number of assumptions and limitations, and you are
cautioned not to give undue weight to such estimates.
References
1. U.S. Cancer
Statistics: Highlights from 2017 Incidence. U.S. Cancer Statistics
Data Briefs, No. 17, June
2020. https://www.cdc.gov/cancer/uscs/about/data-briefs/no17-USCS-highlights-2017-incidence.htm
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
Media Contact
Ellen
Thomas
Evofem Biosciences, Inc.
ethomas@evofem.com
Mobile: (718) 490 -3248
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SOURCE Evofem Biosciences, Inc.