Evofem presents data detailing fewer urinary tract infections in women using Phexxi in the AMPOWER Phase 3 clinical trial
- 5.8% of women in the AMPOWER trial experienced a urinary tract infection during the study, compared to 11% in the general population
- the post hoc The analysis will be presented at the 2022 Annual Meeting of the American College of Obstetricians and Gynecologists (ACOG) in San Diego, California on
May 7, 2022
SAN DIEGO, May 6, 2022 /PRNewswire/ — Evofem Biosciences Inc., (Nasdaq: EVFM) today announced that new data from the AMPOWER Phase 3 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) than the general population.
dr. Bassem Maximethe senior poster author will present this new dataset 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: ACOG 2022 Annual Clinical and Scientific Meeting: Meeting Details (pathable.com).
“In this post hoc women who used Phexxi had significantly fewer UTIs compared to the general population,” said Dr. Bassem Maximelead author of the study and director of Maximos Ob/Gyn in League City, Texas. “These data provide information worthy of further investigation to determine whether Phexxi has an impact on UTIs in women.”
AMPOWER was a single-arm, multicenter, Phase 3 study evaluating the efficacy and safety of Phexxi for the prevention of pregnancy.
Of the 1,339 women who self-administered at least one dose of Phexxi and entered the safety population, 77 (5.8%) experienced a UTI during the study. Of the 77 women who experienced UTIs, one woman experienced an event classified as “bacterial urinary tract infection”; the remaining 76 women had events classified as “urinary tract infection”. Adverse events (≥2%; N=1330) were consistent with the results of the overall study findings.
“The Phase 3 AMPOWER study continues to provide data showing a greater and positive impact on a woman’s sexual, reproductive and general health,” said Saundra Pelletier, Managing Director, Evofem. “Later this year, we will read key data from our EVOGUARD Phase 3 registration trial of Phexxi for the prevention of chlamydia and gonorrhea, which, if approved, could further expand the opportunities for Phexxi. to protect women’s health.
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 health care provider if you experience 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 complete product information at www.phexxi.com.
Please report side effects by contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Intended for US residents only.
About Evofem Biosciences
Evofem Biosciences, Inc., (Nasdaq: EVFM) develops and markets innovative products to address the unmet sexual and reproductive health needs of women, including hormone-free, female-controlled contraception and protection against chlamydia and gonorrhea. The company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a prescription vaginal contraceptive gel without hormones. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each sexual intercourse. Learn more at phexxi.com and evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
This press release contains “forward-looking statements”, within the meaning of the safe harbor for forward-looking statements provided for 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 regarding timing and outcome of Phase 3 registration EVOGUARD trial and any submission or approval of Phexxi to or by the FDA for the prevention of chlamydia and gonorrhea. A variety of factors could cause actual results to differ materially from those discussed or implied by the forward-looking statements, including market and other conditions, and you are cautioned not to place undue reliance on such 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 adversely affect the value of the assets and businesses of Evofem Biosciences, are disclosed in the documents filed by the Company with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 10, 2022. All forward-looking statements are expressly qualified in their entirety by these factors . The Company undertakes no obligation to update forward-looking statements, except as required by law.
Evofem Biosciences, Inc.
Evofem Biosciences, Inc.
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