Our Products

Introducing

Products in Development

Evofem Biosciences is dedicated to developing a portfolio of innovative therapeutic solutions to meet the evolving sexual and reproductive health needs of millions of women globally, including contraception, prevention of recurrent bacterial vaginosis and the prevention of urogenital chlamydia and gonorrhea in women. Our goal is to create woman-controlled, easy-to-use and accessible products. Because when a woman is in complete control today, she is in greater control of tomorrow.

Amphora® for the prevention of pregnancy

Amphora® has been designed as a contraceptive with 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
Not Yet Filed
Contraception
Contraception
Regulatory Filing Not Yet Filed

Amphora® for the prevention of urogenital chlamydia and gonorrhea in women

Our antimicrobial drug product has been granted Qualified Infectious Disease Product (QIDP) status

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
Indication Pre-Clinical Phase 1 Phase 2b/3 Phase 3
Regulatory Filing Phase 3 Phase 2b/3 Phase 1 Pre-Clinical Indication
Not Yet Filed
STIs
Regulatory Filing Not Yet Filed

Antimicrobial multipurpose prevention technology (MPT) vaginal gel for the prevention of recurrent Bacterial Vaginosis (BV)

Our antimicrobial drug product has been granted QIDP status

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(AMP002)

AMP002 is our second pivotal, Phase 3 clinical trial designed to assess the effectiveness of Amphora® 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. Amphora® 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 has enrolled over 1350 women at 115 study centers in the United States. Trial data is expected in the first quarter of 2019.

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Antimicrobial Effects

Chlamydia/Gonorrhea Prevention Clinical Trial
(EVO-003)

EVO-003 is a double-blind, placebo controlled Phase 2b/3 clinical trial designed to assess the ability of Amphora 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 EVO-003 is underway.

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Planned Clinical Trial:
MPT Vaginal Gel for the Prevention of Recurrent Bacterial Vaginosis (BV)

This clinical trial will build upon a Phase 1 dose-finding study, in which pH levels were maintained for 7 days. Trial design is in development.

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