Evofem Biosciences Inc (NASDAQ:EVFM) Announces The Publishing Of Its Phexxi Phase 3 AMPOWER study Findings In Contraception Journal


Evofem Biosciences Inc (NASDAQ:EVFM) recently announced that the clinical findings from its Phase 3 AMPOWER study evaluating Phexxi as contraceptive have been published in a peer-reviewed international journal called Contraception.

The journal published the findings from the AMPOWER study of Phexxi in its website version of the journal. However, it is also expected to release a print version of the publication in the future. Evofem developed phexxi as an on-demand, non-hormonal contraceptive that functions as a vaginal regulator. Its mechanism is designed to facilitate a balance of the vaginal pH between 3.5 and 4.5, an acidic environment that does not allow sperms to survive.

The Food and Drug Administration (FDA) gave its regulatory approval for Phexxi on May 22, 2020, as an on-demand contraceptive based on the favorable clinical data from the Phase 3 AMPOWER study. This means that it is legally approved as a contraceptive that can be used by females with reproductive potential.

“The publication of these pivotal data in such an important, peer-reviewed journal underscores the rigor of the AMPOWER clinical trial and the importance of our novel approach to addressing women’s contraceptive needs,” stated Evofem CEO Saundra Pelletier.

Pelletier also noted that the publication of the clinical data results from the AMPOWER study in the Contraception journal will ensure that clinicians have comprehensive data on phexxi. The CEO also noted that phexxi is the first non-hormonal contraceptive, which means that it allows women to control their reproductive health. The contraceptive will be made available in the form of a gel.

Evofem plans to launch phexxi commercially in September this year in the U.S where it will be available to more than 17 million women. This means that the gel contraceptive has a potentially huge revenue potential while also benefiting women who are tired of using hormonal contraceptives.

As for the clinical findings, phexxi demonstrated very few adverse effects with only 2 percent of the women that participated in it discontinuing prematurely. More than 80 percent of the women in the study were pleased with using phexxi out of 1,325 participants.