Evofem Biosciences, Inc. (NASDAQ: EVFM) (Evofem), a clinical-stage biopharmaceutical company, today reported additional data from its Phase 3 ‘AMPOWER’ clinical trial of Amphora® for the prevention of pregnancy. 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. The analysis also confirmed certain previously reported safety and efficacy data.
AMPOWER is the first clinical study to explore the effects of a contraceptive product candidate on sexual satisfaction.
As part of a sexual satisfaction exploratory endpoint, study participants were asked to answer survey questions (unvalidated instrument) aimed at assessing the impact of their most recent contraceptive method on their sex life at two time points: upon entry into the study (baseline; n=1330) and after using Amphora for one month (n=1118). At baseline, just 17% of study participants reported their most recent contraception made their sex life ‘a little’ or ‘a lot’ better than before. However, after at least one cycle of Amphora use, 45% of women reported their sex life was ‘a little’ or ‘a lot’ better.
“For the first time, we are investigating not only the clinical benefits of a birth control method but also listening to women’s needs throughout their reproductive and sexual health journey,” said Saundra Pelletier, CEO of Evofem Biosciences. “These data, although preliminary, suggest that use of Amphora increased the number of women reporting an improved sex life compared with the contraceptive methods they used before entering the AMPOWER study. If approved, we look forward to launching Amphora in 2020 as the first MVP-R for hormone-free birth control.”
In addition, our third party data and statistics analyst has completed its comprehensive review of the complete data set for our AMPOWER trial, which confirms the favorable safety profile of this first-in-class MVP-R product candidate. During AMPOWER, 1330 women used Amphora and contributed 7561 cycles of safety data. The incidence of serious adverse events (SAEs) was low (1.1%), and none of the SAEs were considered definitely related to treatment with Amphora. Most adverse events (AEs) were mild to moderate in severity, and fewer than 2% of treated subjects discontinued prematurely due to an AE. Pregnancy outcome and infant assessments did not reveal any adverse pregnancy outcomes from participation in the study.