Evofem Biosciences Inc. plans to seek a U.S. approval for its contraceptive vaginal gel Amphora after the medicine, in a late-stage study, met its main goal of preventing pregnancy.
The San Diego-based biopharmaceutical company's stock was up on the Nasdaq by about 13% to $3.99 as of 2:17 p.m. ET compared with the previous day's close.
Evofem evaluated Amphora in about 1,400 women aged 18 to 35 years in a phase 3 trial called Ampower over seven cycles of use. Amphora is a non-hormonal medicine that regulates vaginal pH levels to maintain an inhospitable environment for sperm and certain viral and bacterial pathogens associated with sexually transmitted infections. This level, however, allows for the survival of healthy bacteria in the vagina.
The trial met its main goal by demonstrating a pregnancy rate of 14% over seven cycles, which meant an 86% efficacy rate for the medicine. The company said that when Amphora was used as directed, the pregnancy rate was 1.3% over seven cycles, corresponding to a 98.7% efficacy rate.
Evofem, which completed its reverse merger with Neothetics Inc. in January, said results show that when Amphora is used as directed, women can have confidence that the efficacy is similar to other frequently used contraceptive methods. Little innovation has occurred in women's contraceptives in recent decades despite a market gap for women who cannot or will not take more traditional hormonal birth control, such as the pill.
Evofem CEO Saundra Pelletier said the results "solidify Amphora's position as the most substantial birth control innovation in nearly 20 years," and could be a major advancement for women's sexual and reproductive health.
The company plans to further analyze the data and submit a new drug application to the U.S. Food and Drug Administration in the second quarter of 2019. Amphora secured fast-track designation from the regulator in February. The company plans to commercialize the drug in January 2020.
Evofem is also evaluating Amphora to treat the sexually transmitted infection chlamydia in women.