Photo Credit: Evofem Biosciences
Post written by Tishina Okegbe, FHI 360
Amphora, an investigational Multipurpose Vaginal pH Regulator (MVP-RTM), shows promise for the United States Food and Drug Administration NDA approval in 2020. Amphora comes pre-filled in an easy-to-use applicator and can be used up to an hour before sexual intimacy. Evofem Biosciences, the clinical stage biopharmaceutical company behind Amphora, has recently completed two clinical trials to assess its safety and efficacy to prevent pregnancy as well as sexually transmitted infections. The AMPOWER Phase 3 clinical trial to assess contraceptive efficacy and safety was completed in December 2018 and successfully met its primary endpoint of pregnancy rate over seven cycles of use (one cycle = 21-35 days). The cumulative pregnancy rate was 14.0% with an 86.0% efficacy rate for typical use. Additionally, investigators assessed sexual satisfaction with product use as a secondary endpoint and was the first clinical trial to do so. Interestingly, the data show that women’s sexual satisfaction after at least once cycle of Amphora use increased, with 45% of women reporting that their current contraception made their sex life better compared to 17% of study participants at baseline.
Photo Credit: Evofem Biosciences
In December 2019, AMPREVENCE, a Phase 2b clinical trial to assess Amphora safety and efficacy to prevent urogenital chlamydia and gonorrhea in women was completed. The results showed that Amphora was able to reduce the risk of both chlamydia and gonorrhea infection, and it was safe and well tolerated by study participants.
The launch of Amphora could be a game changer as it would become the first non-hormonal, on demand, woman-controlled contraceptive gel on the market. Further, as a multipurpose technology, Amphora would offer both pregnancy and STI protection to millions of women who have an unmet need for contraception and are at risk for sexually transmitted infections.
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