Phexxi® Prevented 99% of Pregnancies Per Act of Intercourse in a Post Hoc Analysis of Phase 3 AMPOWER Clinical Trial Data

Rhea-AI Summary

Evofem Biosciences (Nasdaq: EVFM) disclosed results from a post hoc analysis of the Phase 3 AMPOWER trial for Phexxi, showing it prevented 99% of pregnancies per act of intercourse. Based on 101 pregnancies from 24,289 acts of intercourse among 1,182 women, this paralleled a pregnancy risk of 0.415%. The FDA-approved Phexxi exhibited a 7-cycle cumulative pregnancy rate of 13.7% with typical use. Previous studies indicated that 88.7% of women reported improved sexual quality of life, while urinary tract infections were lower compared to the general population.

Positive

• Phexxi prevented 99% of pregnancies per act of intercourse based on AMPOWER analysis.
• 88.7% of women using Phexxi reported improvement in their sex life.
• Lower incidence of urinary tract infections (5.8% vs 11.0%) compared to the general population.

Negative

• Pregnancy risk of 0.415% from the analysis was not statistically tested and not included in U.S. Prescribing Information.
• No comparative efficacy data exists between Phexxi and other contraceptives.

• Throughout 24,289 Acts of Intercourse, 101 Pregnancies were Reported with Typical Use of Phexxi in AMPOWER Post Hoc Analysis

SAN DIEGO, June 16, 2022 /PRNewswire/ -- Evofem Biosciences, Inc., (Nasdaq: EVFM) today announced results of a post hoc analysis of the registrational Phase 3 AMPOWER trial investigating the ability of Phexxi^® (lactic acid, citric acid, and potassium bitartrate) to prevent pregnancy.

In the analysis, Phexxi prevented 99% of pregnancies per act of intercourse. This was based on 101 pregnancies (n=1182) over 24,289 acts of intercourse with typical use in 1,182 women. The per-act-of-intercourse pregnancy risk of 0.415% was not statistically tested in AMPOWER and, therefore, is not in the U.S. Prescribing Information (USPI) approved by the FDA.

"Providing data showing how Phexxi performs on-demand to prevent pregnancy per act of intercourse helps women and their doctors better understand Phexxi and the value its innovation adds to the armamentarium of choice," said Saundra Pelletier, Chief Executive Officer of Evofem.

Earlier this year, the Journal of Sexual Medicine published a post hoc analysis of an exploratory endpoint showing that 88.7% of women using Phexxi in AMPOWER improved or maintained their sex life.  Additionally, last month, Evofem presented a post hoc analyses at the American College of Obstetricians and Gynecologists annual clinical and scientific meeting showing that incidences of urinary tract infections in women who used Phexxi in AMPOWER were less compared to the general population (5.8% vs 11.0%, respectively).

The FDA approved Phexxi in May of 2020 based on the registrational AMPOWER trial, which enrolled 1,349 women in the U.S., as well as combined safety data from AMPOWER and a previous Phase 3 trial, AMP-001, which together provided more than 19,000 cycles of exposure in 2,804 women from the U.S. In AMPOWER, Phexxi demonstrated contraceptive efficacy, with a 7-cycle cumulative pregnancy rate of 13.7% (95% CI: 10.0%, 17.5%) with typical use and 6.67% with perfect use (95% CI: 4.61%, 8.73%), corresponding to an efficacy rate of 86.3% and 93.3%, respectively, in preventing pregnancy. Evofem has not studied Phexxi's efficacy and safety in comparison to other contraceptives.

Phexxi's mechanism of action through vaginal pH modulation results in the immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. Phexxi is not a spermicide and does not contain surfactants such as nonoxynol-9, which causes irreversible membrane alterations of the sperm cells thereby damaging the sperm cell membranes and killing the sperm cells.^i,ii

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, 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

ⁱ Schill WB et al. Ultrastructure of human spermatozoa in the presence of the spermicide nonoxynol-9 and a vaginal contraceptive containing nonoxynol-9. Andrologia 1981; 13:42–9.

ⁱⁱ Grimes et al. Spermicide Used Alone for Contraception. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD005218

 

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SOURCE Evofem Biosciences, Inc.

FAQ

What were the results of the Phase 3 AMPOWER trial for EVFM's Phexxi?

The AMPOWER trial's post hoc analysis showed that Phexxi prevented 99% of pregnancies per act of intercourse.

How many pregnancies were reported during the AMPOWER trial for EVFM's Phexxi?

101 pregnancies were reported during 24,289 acts of intercourse in the trial.

What is the pregnancy risk associated with Phexxi according to the AMPOWER analysis?

The pregnancy risk was calculated at 0.415% per act of intercourse, but it was not statistically tested.

What improvements did women report while using Phexxi in the AMPOWER trial?

88.7% of women reported that their sex life improved or was maintained while using Phexxi.

How does Phexxi compare to the general population in terms of urinary tract infections?

The incidence of urinary tract infections in women using Phexxi was lower at 5.8%, compared to 11.0% in the general population.