- 88.7% of Women Using Phexxi® (lactic acid, citric acid, and
potassium bitartrate Vaginal Gel) Improved or Maintained their Sex
Life According to Exploratory Data Collected During the Phase 3
AMPOWER Clinical Trial
- Women in the Study Provided Data Measured by 10 Variables
Ranging from the Ability to Climax to Interest in Having
Sex
- Phexxi is FDA Approved to Prevent Pregnancy
SAN
DIEGO, April 19, 2022 /PRNewswire/ -- Evofem
Biosciences, Inc., (Nasdaq: EVFM) today
announced the Journal of Sexual Medicine, a peer-reviewed medical
journal, published data collected from Evofem's Phase 3 AMPOWER
clinical trial. Analysis of exploratory endpoints shows that 88.7%
of women using Phexxi® (lactic acid, citric acid, and
potassium bitartrate) reported improvement (n=44.7%) in or the
maintenance (n=44%) of their sexual satisfaction. The publication
can be found here:
https://www.jsm.jsexmed.org/article/S1743-6095(22)00831-1/fulltext
"Phexxi offered the women in this study a non-hormonal,
woman-controlled, on-demand contraceptive gel that clearly provided
a unique set of positive benefits on their sexual health and
enjoyment," said Dr. Todd Chappell,
a clinical investigator and practicing obstetrician and
gynecologist. "Publishing these data provides people and their
health care providers with information about the impact Phexxi can
have on sexual satisfaction."
The AMPOWER study enrolled healthy women between 18 and 35 who
were sexually active with regular cyclic menses. More women
reported satisfaction with Phexxi compared to their previous birth
control method, and more than 93% percent of women in the study
said they were likely to recommend Phexxi.
Investigators leading the trial asked 1330 women questions
related to sexual satisfaction in the study. Specifically,
patient-reported outcomes related to sexual satisfaction derived
from the following:
- A question related to the impact of the previous/current
contraceptive on a woman's sex life
- 10 questions from the Sexual Function Questionnaire related to
the frequency of ten sexual problems
- 19 questions from the Female Sexual Function Index related to
lubrication
The Phase 3 AMPOWER clinical trial primarily sought to determine
the ability of Phexxi to prevent pregnancy in 18 to 35-year-old
women. In this trial, women's sexual satisfaction was listed as an
exploratory endpoint, with the post-hoc exploratory analysis of
sexual satisfaction.
"The AMPOWER study provided first-time insights on several
issues related to sexual and reproductive health, and Evofem is
grateful to all those who participated in our trial," said
Saundra Pelletier, Chief Executive
Officer, Evofem. "Intimacy is about so much more than reproduction.
These data allow us to understand insights into women's sexual
health and sexual satisfaction with the hope of ultimately
improving their intimate experiences. Evofem will continue the
research necessary to further scientific discourse and seek new and
better ways to enhance sexual and reproductive health."
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 infections 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 sexually transmitted
infections, including HIV.
For more information about Phexxi, talk to your healthcare
provider and see full Product Information
at www.phexxi.com.
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.
Intended for United States residents only.
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 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. 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, 2021, filed with the SEC on March 10,
2022. 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.
Media Contact
Jack Hirschfield
Evofem Biosciences, Inc.
jhirschfield@evofem.com
(512) 674-5163
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
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SOURCE Evofem Biosciences, Inc.