Evofem Biosciences, Inc., (Nasdaq: EVFM) today presented data at the Academy of Managed Care Pharmacy (AMCP) annual meeting showing EVO100 (the investigational name for Phexxi®) provided a significant decrease in gonorrhea and chlamydia infections in women as well as additional patient health outcomes related to satisfaction with use of the investigational product. The results are based on Evofem’s Phase 2B/3 AMPREVENCE clinical trial. Additional data from the AMPREVENCE trial were collected to evaluate information regarding patient satisfaction and adherence to the treatment.
“Findings from these analyses demonstrate the significant impact EVO100 can potentially have in reducing the incidence of chlamydia and gonorrhea as well as set the stage with health insurers and pharmacy benefit managers for access to this investigational product, if approved for the additional indications,” said Brandi Howard, PhD, Head of Medical and Clinical Affairs at Evofem and leader of the AMPREVENCE trial. “We continue to see notable increases in chlamydia and gonorrhea diagnoses in the United States, suggesting that additional options to prevent these infections are needed. We look forward to the topline data readout from the EVOGUARD trial later this year.”
AMPREVENCE was a randomized, controlled Phase 2B/3 trial, with 860 sexually active women between the ages of 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 chlamydia infection rate in EVO100 users was 4.8% (14/289) compared to 9.7% (28/290) among placebo users (P=0.0256), representing a relative risk reduction of 50%. For gonorrhea, the infection rate was 0.7% (2/280) in the EVO100 arm compared to 3.2% (9/277) in the placebo arm (P=0.0316), a relative risk reduction of 78%.
Adverse events, which were genitourinary in nature, were in line with previous trials investigating Phexxi.
“We learned a lot from this Phase 2B/3 trial and were eager to apply those learnings to the confirmatory and registrational Phase 3 EVOGUARD study,” said Dr. Todd Chappell, a practicing obstetrician and gynecologist, the lead investigator for the AMPREVENCE trial and an investigator in the EVOGUARD trial. “We increased the size of the Phase 3 EVOGUARD trial, making it the largest ever to evaluate efficacy and safety in the prevention of chlamydia and gonorrhea, and we hope to provide further and more definitive evidence that, if approved, EVO100 can offer women the chance to protect themselves from these sexually transmitted infections and potentially provide improved satisfaction with use.”
In March of 2021, the American Journal of Obstetrics and Gynecology published the full data set from the AMPREVENCE trial.
Topline data from the Phase 3 confirmatory and registrational EVOGUARD 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 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.
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 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 preventing 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.
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