Evofem Biosciences has announced that the Food and Drug Administration (FDA) acknowledged receipt of the New Drug Application (NDA) resubmission for Amphora (L-lactic acid, citric acid and potassium bitartrate) for the prevention of pregnancy.
Amphora is an investigational multipurpose vaginal pH regulator (MVP-R) designed to regulate vaginal pH within the range of 3.5 to 4.5 even in the presence of semen. The acidic vaginal pH is believed to create an inhospitable environment for semen and certain viral and bacterial pathogens associated with sexually transmitted infections. The vaginal gel is self-applied using a prefilled applicator up to 1 hour prior to sexual intimacy.
The NDA resubmission in November 2019 was supported by full results from the phase 3 AMPOWER study, which evaluated the efficacy and safety of Amphora gel over 7 cycles of use in women aged 18 to 35 years who were at risk of pregnancy (N=1384).
A Prescription Drug User Fee Act (PDUFA) target date of May 25, 2020 has been assigned to the application.
“Today’s acknowledgement brings us one step closer to delivering the first true contraceptive innovation in decades,” said Saundra Pelletier, Evofem Biosciences’ CEO. “We look forward to continuing to work closely with the FDA during the review process and to the potential to offer women a new, non-hormonal prescription contraceptive option that puts them in control of their sexual health.”
The Company is currently investigating the use of Amphora in the AMPREVENCE trial for the prevention of urogenital chlamydia and gonorrhea in women.
For more information visit evofem.com.