The New Drug Application (NDA) for Amphora (L-lactic acid, citric acid, potassium bitartrate gel; Evofem Biosciences), an investigational multipurpose vaginal pH regulator, has been resubmitted to the Food and Drug Administration (FDA) for the prevention of pregnancy.
Amphora is designed to regulate vaginal pH in the range of 3.5 to 4.5, maintaining an acidic environment even in the presence of semen, making it inhospitable to sperm and certain viral and bacterial pathogens associated with sexually transmitted infections. The vaginal gel is self-applied using a prefilled applicator.
The NDA resubmission includes data from the phase 3 AMPOWER study that evaluated the safety and efficacy of Amphora gel over 7 cycles of use in women aged 18 to 35 years who were at risk of pregnancy (N=1384); the study was designed to address the questions raised in the Complete Response Letter the Company received from the FDA in 2016.
Results from the study showed a cumulative pregnancy rate of 14.0% over 7 cycles of use (95% CI 10.0, 18.0), corresponding to an 86.0% efficacy rate with typical use. In women who correctly used Amphora as directed, the cumulative pregnancy rate was 1.3% over 7 cycles of use (95% CI 0.4, 2.1), corresponding to a 98.7% efficacy rate. Moreover, additional findings from the study showed an improvement in sexual satisfaction with Amphora use based on survey results.
“Today’s submission represents a significant step forward for Evofem and for the millions of women who are dissatisfied with their current contraceptive options and are eagerly awaiting a new alternative,” said Saundra Pelletier, Evofem Biosciences’ Chief Executive Officer. “We have submitted a comprehensive and compelling package that we believe addresses the Agency’s outstanding questions, and we look forward to the potential opportunity to provide millions of women with an innovative new hormone-free, on-demand, prescription contraceptive option that gives them control over their sexual and reproductive health.”
The FDA is expected to make a decision on the NDA within 6 months.
Amphora is also being investigated in the AMPREVENCE trial for the prevention of acquisition of chlamydia and gonorrhea in women.
For more information visit evofem.com.