Citric acid + lactic acid + potassium bitartrate

Unassigned

New Medicines

Amphora Contraception

Information

Amphora
New molecular entity
Evofem Biosciences
Evofem Biosciences

Development and Regulatory status

None
None
Approved (Licensed)
May 20Approved in US for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception [7].
Nov 19Filed in US [5].
Mar 19In its annual report, Evofem notes that an analysis of secondary market research from 2017 suggests that approximately 60 million of women in the greater European market (inclusive of the EU), eastern Europe, and the Commonwealth of Independent States were found to showcase the characteristic of hormone avoidance or were hormone indifferent. Evofem believe Amphora will have the ability to significantly grow the European birth control market through the conversion of non-users, hormonal contraceptive users, and those who will supplement their current methods. Evofem is currently assessing how Amphora is going to be regulated in the EU and expects it is going to be regulated as a drug. No plans for EU filing described [6].
Dec 18Resubmission of NDA to FDA is planned for Q2 2019 [1].

Category

Multipurpose vaginal pH regulator (MVP-R), designed to restrict vaginal pH to within the normal range of 3.5 to 4.5, which is not conducive to sperm [2]
75% of women aged 16-49 years use some type of contraception, 25% of women use the combined oral contraceptive pill [3].
Contraception
Vaginal

Trial or other data

Jun 19Though key opinion leaders (KOLs) stressed the need for non-hormonal contraceptive options, they were sceptical about Amphora’s efficacy and expressed some doubt about its potential to prevent pregnancy when used as a sole method of contraception. They suggested it will become a method that ultimately should be recommended along with a second barrier method for control, which may reduce its popularity [4].
Dec 18Evofem Biosciences announce positive topline results from PIII Ampower study. The primary endpoint of Ampower (n=1,400), pregnancy rate over seven cycles of use, was 14.0% (corresponding to an 86.0% efficacy rate). In the study protocol, the cumulative pregnancy rate was 1.3% over seven cycles (98.7% efficacy rate) [1].