Evofem Biosciences, Inc. has announced resubmission of New Drug Application (NDA) to the Food and Drug Administration (FDA). This drug is “Amphora” which is used to prevent the pregnancy (a type of contraceptive) and a Multipurpose Vaginal pH Regulator (MVP-R). This announcement was made in SAN DIEGO on Nov 26, 2019.
Evofem Biosciences, Inc. is a clinical-stage biopharmaceutical company. The company is aimed to develop and commercialize new products to meet the needs of women about sexual and reproductive health. The company eagerly developed innovative products and solution including the woman contraceptive, protection from STDS and STIs. So, the company launched a product that leads the multipurpose vaginal Regulator pH
According to the “Saundra Pelletier”, the Chief Executive Officer at Evofem Biosciences that today most of the women are not satisfied by the currently available contraceptives for the prevention of their pregnancy. So, they are looking for an alternative drug that solves their vaginal problems with great efficiency. The resubmission of NDA for the Amphora to the FDA proves the significant effort of Evofem.
The company submitted a convincing and complete package that addresses the Agency’s Questions effectively. Because we are waiting for the opportunity of providing the best option for women with a drug that is free from hormones. The drug is suitable for the contraceptive prescription which controls the sexual and reproductive health of the women.
The resubmission of the NDA for Amphora based on the outcomes of the following confirmatory tests and clinical trials such as confirmatory single-arm, Phase 3 AMPOWER study and the open-label Phase 3 trial. To address the questions raised by the Agency in Complete Response Letter on APRIL 16, the trails were designed and conducted according to the FDA standards and guidelines These trials were conducted in approximately 1400 women of 18 years to 35 years having a stable health record to evaluate the efficacy and safety margin.
Based on the classification system by FDA the application was considered as Class 2 resubmission. It is expected to complete the FDA review about the Class 2 resubmission within the duration of six months that was started at the time when resubmission is received.
It is an investigational drug for the Multipurpose Vaginal Ph Regulator. Amphora is used to regulate the vaginal pH in a narrow range of 3.5 to 4.5. this drug is effective in semen presence which raises the pH to a high level of 7.0 to 8.0. As the nature of the sperms is acidic and it requires the acidic environment for fertilization.
This drug maintained an acidic pH, which also prevents it from viral and bacterial pathogens associated with STDS but it is important for maintaining the healthy bacterial environment in the vagina. Amphora is developed for the prevention of pregnancy, prevention of urogenital transmission of NEISSERIA GONORRHOEOE infections, and chlamydia trachomatis infections