Evofem Presents Positive Encore Data in Sexually Transmitted Infections Impacting Women at the 2022 Academy of Managed Care Pharmacy Annual Meeting
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 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.
Important Safety Information
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
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
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SOURCE Evofem Biosciences, Inc.
Company Codes: NASDAQ-NMS:EVFM