Evofem Presents Data Detailing Fewer Urinary Tract Infections in Women Using Phexxi in the Phase 3 AMPOWER Clinical Trial

Rhea-AI Summary

Evofem Biosciences (Nasdaq: EVFM) announced findings from the Phase 3 AMPOWER clinical trial of Phexxi, revealing a significantly lower urinary tract infection (UTI) rate among participants, with only 5.8% experiencing UTIs compared to 11% in the general population. The results will be presented on May 7, 2022, at the ACOG Annual Meeting. The study involved 1,339 women and aimed to assess Phexxi's efficacy for pregnancy prevention. Evofem anticipates further data later this year from the Phase 3 EVOGUARD trial, which could enhance Phexxi's market potential for preventing chlamydia and gonorrhea.

Positive

• 5.8% UTI rate in AMPOWER trial participants, lower than the general population (11%).
• Upcoming presentation at ACOG Annual Meeting on May 7, 2022, to share new findings.
• Potential market expansion with data expected from the Phase 3 EVOGUARD trial later this year.

Negative

• None.

• 5.8% of Women in the AMPOWER Trial Experienced an On-Study Urinary Tract Infection Compared to 11% in the General Population
• The Post hoc Analysis will be Presented at the 2022 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting in San Diego, CA on
  May 7, 2022

SAN DIEGO, May 6, 2022 /PRNewswire/ -- Evofem Biosciences, Inc., (Nasdaq: EVFM) today announced that new data from the Phase 3 AMPOWER clinical trial of Phexxi^® (lactic acid, citric acid, and potassium bitartrate) showed that women enrolled in the AMPOWER trial had fewer urinary tract infections (UTIs) compared to the general population.

Dr. Bassem Maximos, the lead author of the poster will present this new data set at the American College of Obstetricians and Gynecologists (ACOG) Annual Meeting on Saturday, May 7, 2022. Details of the presentation and data can be found here: 2022 ACOG Annual Clinical and Scientific Meeting: Meeting Details (pathable.com).

"In this post hoc analysis women who used Phexxi experienced significantly fewer UTIs compared to the general population," said Dr. Bassem Maximos, lead author of the study and Head of Maximos Ob/Gyn in League City, Texas. "These data provide insights worthy of further investigation to determine if Phexxi has an impact on UTIs in women."

AMPOWER was a Phase 3, single-arm, multicenter study that evaluated the efficacy and safety of Phexxi for the prevention of pregnancy.

Of the 1339 women who self-administered at least one dose of Phexxi and were included in the safety population, 77 (5.8%) experienced an on-study UTI. Of the 77 women who experienced UTIs, one woman experienced an event that was classified as "urinary tract infection bacterial"; the remaining 76 women had events classified as "urinary tract infection". Adverse events (≥2%; N=1330) were congruent with the results from the overall study findings.

"The Phase 3 AMPOWER study continues to provide data showing a larger and positive impact on a woman's sexual, reproductive, and general health," said Saundra Pelletier, Chief Executive Officer, Evofem. "Later this year will read out top-line data from our registrational Phase 3 EVOGUARD trial investigating Phexxi for the prevention of chlamydia and gonorrhea, which, if approved, could further expand Phexxi's opportunities to protect women's 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 provide 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 including, without limitation, statements related to timing and outcome of the registrational Phase 3 EVOGUARD trial and any submission or approval of Phexxi to or by the FDA for the prevention of 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, 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.

FAQ

What were the results of the AMPOWER trial for Phexxi (EVFM)?

The AMPOWER trial showed that only 5.8% of women experienced urinary tract infections, significantly lower than the 11% rate in the general population.

When will the results from the AMPOWER trial be presented?

The findings will be presented on May 7, 2022, at the American College of Obstetricians and Gynecologists (ACOG) Annual Meeting.

What is the Phase 3 EVOGUARD trial investigating for Evofem Biosciences?

The EVOGUARD trial is investigating Phexxi for the prevention of chlamydia and gonorrhea, with data expected later this year.

How effective is Phexxi in preventing urinary tract infections?

In the AMPOWER trial, women using Phexxi experienced significantly fewer urinary tract infections compared to the general population.