Evofem Presents Still Positive Data on Sexually Transmitted Infections Affecting Women at the 2022 Annual Meeting of the Academy of Managed Care Pharmacy
Phase 2B/3 AMPREVENCE clinical trial concluded with women experiencing a 50% reduction in the risk of Chlamydia Trachomatis (chlamydia) and a 78% reduction in the risk of Neisseria Gonorrhoeae (gonorrhea) using EVO100 (experimental name of Phexxi® (lactic acid, citric acid and potassium bitartrate)) Compared to placebo
AMPREVENCE also incorporated direct patient health outcomes related to sexual satisfaction
Positive AMPREVENCE data serves as basis for ongoing, confirmatory, registrational Phase 3 EVOGUARD trial studying EVO100 to prevent chlamydia and gonorrhea in women
Key data from the EVOGUARD Phase 3 trial are expected in the second half of 2022
SAN DIEGO, March 31, 2022 /PRNewswire/ — Evofem Biosciences, Inc., (Nasdaq: EVFM) today presented data at the Academy of Managed Care Pharmacy (AMCP) annual meeting showing EVO100 (the investigational name of Phexxi®) provided a significant decrease in gonorrhea and chlamydia infections in women as well as additional patient health outcomes related to satisfaction with the use of the investigational product. The results are based on the phase of Evofem 2B/3 AMPREVENCE clinical trial. Additional data from the AMPREVENCE trial were collected to assess information regarding patient satisfaction and adherence to treatment.
“The results of these analyzes demonstrate the significant impact that EVO100 can potentially have in reducing the incidence of chlamydia and gonorrhea, and set the stage for health insurers and pharmacy benefit managers to access to this investigational product, if approved for the additional indications,” said Brandi Howard, PhD, Head of Medical and Clinical Affairs at Evofem and Lead of the AMPREVENCE trial. “We continue to see notable increases in chlamydia and gonorrhea diagnoses in United States, suggesting that additional options to prevent these infections are needed. We look forward to reading the key data from the EVOGUARD trial later this year.”
AMPREVENCE was a randomized, controlled phase 2B/3 trial, with 860 sexually active women aged 18-45 who had documented chlamydia or gonorrhea infections within 16 weeks of enrollment.
In the AMPREVENCE study, EVO100 reduced the overall risk of chlamydia by 50% and the risk of gonorrhea by 78%. The rate of chlamydia infection in EVO100 users was 4.8% (14/289) versus 9.7% (28/290) in placebo users (P=0.0256), representing a 50% relative risk reduction. For gonorrhea, the infection rate was 0.7% (2/280) in the EVO100 arm versus 3.2% (9/277) in the placebo arm (P = 0.0316), i.e. a reduction in relative risk of 78%.
Adverse events, which were genitourinary in nature, were consistent with previous trials of Phexxi.
“We learned a lot from this phase 2B/3 and were eager to apply this knowledge to the EVOGUARD Phase 3 confirmation and registration study,” said Dr. Todd Chappell, practicing obstetrician-gynecologist, principal investigator of the AMPREVENCE trial and investigator of the EVOGUARD trial. “We have increased the size of the Phase 3 EVOGUARD trial, making it the largest ever to assess efficacy and safety in the prevention of chlamydia and gonorrhea, and we hope to provide evidence additional and more definitive that, if approved, EVO100 may offer women the chance to protect against these sexually transmitted infections and potentially improve user satisfaction.”
In March 2021, the American Journal of Obstetrics and Gynecology published the full dataset from the AMPREVENCE trial.
The first data from the EVOGUARD Phase 3 confirmatory and registration trial are expected in the second half of 2022.
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 relating to the timing and outcome of the confirmatory Phase 3 trial, any submission or approval of Phexxi to or by the FDA for the prevention of chlamydia and gonorrhea, and the size of the market opportunity in 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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