Recently, Evofem Biosciences, a clinical biopharmaceutical company dedicated to developing and commercializing innovative technology for women’s sexual and reproductive health, has announced that it has applied for approval from the U.S. Food and Drug Administration for Amphora, which is a Multipurpose Vaginal pH Regulator (MVP-R) for the prevention of pregnancy.
Currently, there are a number of ways that help in preventing pregnancy in women. Some of the most common ones include taking oral birth control pills, intrauterine devices (IUD), and emergency contraceptives or ‘morning-after’ pill. Other methods that a number of women choose are getting a contraceptive implant, contraceptive ring, diaphragm, and contraceptive injections. Additionally, some women also choose to get sterilization through minimal or invasive surgery which is permanent and cannot be reversed.
Although there are many options available, most of them come with unwanted negative impacts. The most prevalent method, which is taking birth control pills, has been proven to be linked to hormonal disruptions, issues related to the ovaries and uterus, cysts, skin conditions, and worsening of depression, anxiety, and suicidal thoughts.
Therefore, there is now constant research on new methods to successfully prevent pregnancy in women as well as in men to reduce the many side effects associated with the previous methods of contraception.
The Chief Executive Officer of Evofem Biosciences, Saundra Pelletier, comments that the submission of application for the approval of Amphora can add to the different contraception options for women and the ones who are not content with their current contraceptive method can try the new technology.
She adds that Amphora can also potentially change contraception for women as it provides a new, innovative way of avoiding pregnancy with comparatively fewer side effects as it is a prescription-based, hormone-free, and on-demand method which may be more satisfying for the majority of women as they will have more control over their sexual and reproductive health.
The new application for Amphora includes results and observations from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial. In this clinical trial, the safety, effects, and efficiency of the technology were evaluated. The participants included around one thousand and four hundred healthy women between the ages of eighteen to thirty-five.
Evofem Biosciences’s application for the approval of Amphora is a re-submission. Therefore, the new trial was designed in accordance with the guidelines and instructions from the U.S. Food and Drug Administration itself from the response letter received by the company after the first application in the year 2016.
Now, the re-submission of the application will be considered a Class 2 resubmission under the official classifications of the FDA. Applications under the Class 2 category are expected to be completed within a time period of six months starting from the date the application is resubmitted in accordance with Drug User Fee Act (PDUFA) from the FDA.
Consequently, Evofem Biosciences’s Amphora may or may not get approval in the middle of the upcoming year. An FDA approval may then pave the way for the commercialization and availability of Amphora technology in the market in 2020.