Our Products

Introducing

Products in Development

Evofem Biosciences is dedicated to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem is leveraging its proprietary Multipurpose Vaginal pH Regulator (MVP-R)TM to develop product candidates for multiple indications, including contraception, the prevention of urogenital transmission of chlamydia and gonorrhea in women, and recurrent bacterial vaginosis.

Phexxi™ - an investigational candidate for the prevention of pregnancy

As a Multipurpose Vaginal pH Regulator (MVP-R)TM Phexxi is a Multipurpose Vaginal pH Regulator (MVP-R)™ designed to regulate vaginal pH within the normal range of 3.5 to 4.5 even in the presence of semen. Top-line data from the Phase 3 AMPOWER study demonstrate that Phexxi met the pre-specified primary endpoint of this trial, and no serious treatment-related adverse events were reported. Phexxi is currently being reviewed by the U.S. Food and Drug Administration (FDA) for prevention of pregnancy and has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2020.

Phexxi is designed to offer unique attributes to fit a woman’s needs:
  • Hormone free: for those who have a contraindication for or are uncomfortable adding hormones to their body
  • Woman-controlled: empowers women to control over their contraception choice
  • Use as needed: no need to take a pill every day or have an implant; can be used up to one hour before sexual intimacy
  • Easy-to-use: self-applied contraception in an easy-to-use pre-filled applicator
Indication Pre-Clinical Phase 1 Phase 2 Phase 3
Regulatory Filing Phase 3 Phase 2 Phase 1 Pre-Clinical Indication
Filed Nov. 2019
Contraception
Contraception
Regulatory Filing Filed Nov. 2019

EVO100 – an investigational candidate for the prevention of urogenital chlamydia and gonorrhea in women

Our MVP-RTM drug candidate EVO100 has been granted Qualified Infectious Disease Product (QIDP) status by the U.S. Drug and Food Administration.

It is designed to reduce certain vaginal infections by:
  • Creating an environment that is a conducive to maintaining healthy vaginal flora but is detrimental to the growth and proliferation of harmful bacteria
  • Using a different mechanism of action that may help to address drug resistance concerns

  • The Phase 2b AMPREVENCE study evaluating EVO100 for the prevention of chlamydia and gonorrhea met its primary and secondary endpoints, and EVO100 was generally safe and well tolerated.
Indication Pre-Clinical Phase 1 Phase 2b Phase 3
Regulatory Filing Phase 3 Phase 2b Phase 1 Pre-Clinical Indication
Not Yet Filed
STIs
Regulatory Filing Not Yet Filed

Multipurpose Vaginal pH Regulator (MVP-R)TM for the prevention of recurrent Bacterial Vaginosis (BV)



It is in development to assess its ability to:
  • Kill many BV-associated pathogenic bacteria which has been demonstrated in vitro data
  • Balance vaginal pH, thereby supporting normal vaginal flora and eliminating odor associated with BV
IndicationPre-ClinicalPhase 1Phase 2Phase 3
Regulatory FilingPhase 3Phase 2Phase 1Pre-ClinicalIndication
Not Yet Filed
BV
Regulatory Filing Not Yet Filed

These products have not been approved for marketing by the US Food and Drug Administration or any other regulatory agency.

Clinical Trials

Prevention of Pregnancy

Contraceptive Clinical Trial (AMPOWER)

AMPOWER is Evofem’s second pivotal, Phase 3 clinical trial designed to assess the effectiveness of Phexxi in preventing pregnancy and to evaluate its safety over 7 menstrual cycles of use in women who are using no other forms of birth control. Phexxi is a novel, non-hormonal birth control designed to maintain the pH of the vagina to inhibit sperm motility and to form a layer of gel over the vagina and cervix, preventing sperm from reaching an egg. The study enrolled approximately 1,400 women at 115 study centers in the United States. The top-line data met the pre-specified primary endpoint of this trial, and Phexxi had a favorable safety profile and was well tolerated.

Antimicrobial Effects

Chlamydia/Gonorrhea Prevention Clinical Trial
(AMPREVENCE)

AMPREVENCE is a double-blind, placebo controlled Phase 2b clinical trial designed to assess the ability of EVO100 to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. Approximately 850 women will be enrolled at about 50 sites in the United States for a 4-month interventional period followed by a 1-month follow-up period. Enrollment in AMPREVENCE was completed in March 2019, and top-line results were reported in December of 2019. The study met its primary and secondary endpoints, and EVO100 was generally safe and well tolerated.