Evofem Announces First Patient Enrolled In A Phase III Clinical Trial Of AMPHORA (L-Lactic Acid, Citric Acid, And Potassium Bitartrate) For Prevention Of Pregnancy
SAN DIEGO, July 27, 2017 /PRNewswire/ -- Evofem Biosciences, Inc., a biotechnology company focused on the development and commercialization of women's health products, today announced the enrollment of the first patient in a Phase 3 clinical trial evaluating AMPHORA® for the prevention of pregnancy. AMPHORA is an investigational compound being studied as a vaginal contraceptive and for the prevention of certain vaginal infections.
"We designed this study to be supportive of our first Phase 3 trial that demonstrated the non-inferiority of AMPHORA compared to another marketed form of contraception over 7-cycles of use," said Brandi Howard, PhD, Evofem's VP of Global Clinical Development & Medical Affairs. "We believe this study will confirm our previous results and provide additional scientific evidence to augment AMPHORA's current efficacy and safety profile."
Known as AMPOWER (A Single-Arm, Phase III, Open-Label, Multicenter, Study in Women Aged 18-35 Years of the Contraceptive Efficacy and Safety of AMPHORA® Contraceptive Vaginal Gel), this trial is expected to enroll approximately 1,350 women at risk of pregnancy at over 100 centers in the United States. The primary endpoint is the contraceptive efficacy of AMPHORA over seven cycles of use.
"We were able to exceed expectations by enrolling our first patient in the AMPOWER study on July 27, 2017, and estimate that the AMPOWER study is now on track to be completed in Q4 2018. This is a pivotal step in the development of AMPHORA, and we are focused on executing this study and providing the results to the FDA," said Saundra Pelletier, Evofem Biosciences' CEO. "We believe that the novel, non-hormonal attributes of AMPHORA can provide women with a much needed, new option for birth control."
AMPHORA is an investigational novel, non-hormonal, surfactant-free new drug being studied as a vaginal contraceptive and for the prevention of certain vaginal infections. For contraception, AMPHORA is being developed to fill a gap in the birth control landscape for women who are dissatisfied with current available options, such as those who are reluctant to use hormonal contraceptives due to side effects or for whom hormonal contraceptives are contraindicated. AMPHORA has been designed for women who prefer rapidly reversible, nondaily and/or on-demand contraception, experience allergy or sensitivity to N-9, or do not want to rely solely on a partner's collaboration. The development of AMPHORA also includes compatibility studies to determine if AMPHORA can be used concomitantly with barrier methods, such as diaphragms and condoms, for women who prefer to use multiple types of contraceptives simultaneously.
About Evofem Biosciences
Evofem Biosciences develops and commercializes innovative products that support and promote women as the primary healthcare consumer. Evofem Biosciences is currently identifying and developing new and novel products that specifically address unmet needs in the areas of sexual and reproductive health, the prevention of acquisition of sexually transmitted infections and products that address or promote general health and wellbeing. For more information on the Company, visit www.evofem.com.
Statements in this press release about Evofem Biosciences' future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the results of the AMPOWER study and the expected completion date for the AMPOWER study.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Evofem Biosciences' product candidates will advance through the clinical trial process on a timely basis, or at all; whether Evofem Biosciences' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed. In addition, the forward-looking statements included in this press release represent Evofem Biosciences' views as of the date hereof. Evofem Biosciences anticipates that subsequent events and developments will cause its views to change. However, while Evofem Biosciences may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Evofem Biosciences' views as of any date subsequent to the date hereof.
Evofem Biosciences Media Contact
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SOURCE Evofem Biosciences