drugset
Drugs / AMPHORA
last change Aug 2025 re-read 9 days ago

AMPHORA

also known as Phexxi
Investigated by
Evofem Inc. · Parexel · Premier Research

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed US (FDA) — pregnancy prevention 2019-11-26

“resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Amphora®” evofem.com ↗

“FDA acknowledged receipt of the New Drug Application (NDA) resubmission for Amphora” evofem.com ↗

Trials 2

today NCT03243305 · Ph 3 NCT01306331 · Ph 3
20112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT03243305 Jul 2017 → Nov 2018 — Evofem Inc. Completed Met primary
Phase 3 NCT01306331 Apr 2011 → Jun 2014 — Evofem Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2021-11-10 Evofem Inc. Regulatory Evofem Biosciences Announces Regulatory Submission in Mexico for Its Hormone-Free Contraceptive evofem.com ↗
today announced that it has submitted the registration for its hormone-free contraceptive vaginal gel to the Mexican Regulatory Agency COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).
2019-12-18 Evofem Inc. Regulatory U.S. FDA Acknowledges Receipt of Evofem Biosciences' New Drug Application Resubmission for Amphora® for the Prevention of Pregnancy evofem.com ↗
Deemed a Class 2 resubmission by the FDA, the agency has assigned a six-month review period and a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2020 .
2019-12-02 Evofem Inc. Results Evofem Biosciences Reports Positive Top-Line Results from Phase 2b Study of Amphora® for Prevention of Chlamydia and Gonorrhea in Women evofem.com ↗
The study met both its primary and secondary endpoints of reducing the risk of chlamydia and gonorrhea infection, respectively, and demonstrated that Amphora was generally safe and well tolerated.
2019-11-26 Evofem Inc. Regulatory Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy evofem.com ↗
Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Amphora®, a Multipurpose Vaginal pH Regulator (MVP-R™), for the prevention of pregnancy.
2019-08-05 Evofem Inc. Results Evofem Biosciences Reports Additional Data from Phase 3 'AMPOWER' Study of Amphora® for Hormone-Free Birth Control evofem.com ↗
These findings reveal that the use of Amphora, a first-in-class investigational Multipurpose Vaginal pH Regulator (MVP-R™), may improve sexual satisfaction and have a positive impact on women's sex lives.
2018-12-17 Evofem Inc. Results Evofem Biosciences Announces Positive Top-Line Results of Phase 3 Study Evaluating Amphora for Hormone-Free Birth Control evofem.com ↗
Top-line data analysis demonstrates a cumulative pregnancy rate of 14.0% over seven cycles of use (95% CI 10.0, 18.0).
2018-10-09 Evofem Inc. Results Data on Patient Acceptability and Genitourinary Effects of Evofem Biosciences' Lead Product Candidate, Amphora, and its Role as a Multipurpose Vaginal pH Regulator Presented at 2018 American Society of Reproductive Medicine Annual Congress evofem.com ↗
Results from the acceptability questionnaire in AMP001 demonstrated that Amphora was the preferred choice of birth control method in women users over the 6-month study period and acceptability remained high after cycle 13.
2018-02-21 Evofem Inc. Regulatory Evofem Biosciences Receives Fast Track Designation for Amphora for Prevention of Chlamydia evofem.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Amphora® (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of urogenital chlamydia in women.

All press releases naming this drug 72 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as AMPHORA ClinicalTrials.gov intervention name — accepted as the source's own label NCT03243305 ↗
1

NCT01306331 ↗
Known as Phexxi “Phexxi™ (Previously Referred to as AMPHORA®) Contraceptive Vaginal Gel” NCT03243305 ↗
1

“This vaginal gel is called Phexxi™ (previously known as Amphora)” NCT01306331 ↗