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Posters Focus on Perfect-Use Efficacy Data and Sexual Satisfaction and Function Among Women in the Phase 3 AMPOWER Trial
SAN DIEGO, April 21, 2021 /PRNewswire/ -- Evofem Biosciences, Inc., (NASDAQ: EVFM) today announced the company will deliver the keynote address and present two poster presentations on Phexxi® (lactic acid, citric acid, potassium bitartrate) at the upcoming NCODA 2021 National Spring Forum, which will be held April 28 to 30 as a virtual E-Meeting.
CEO Saundra Pelletier will deliver a keynote address entitled Evofem Biosciences and NCODA Partnering to Raise Awareness About Phexxi: Supporting the Reproductive and Sexual Health of Women with Cancer on Wednesday, April 28 at 12:05pm PT.
"We look forward to engaging with the NCODA membership at the 2021 National Spring Forum among other ongoing initiatives to ensure that female cancer patients and their oncology teams are aware that there is an FDA-approved, hormone-free, non-invasive contraceptive available: Phexxi," said Ms. Pelletier.
Following the 2021 National Spring Forum, the National Community Oncology Dispensing Association (NCODA) will publish a Positive Quality Intervention (PQI) in connection with Phexxi. PQIs are part of the NCODA Quality Standards. These resources are designed to operationalize and standardize practices to achieve positive outcomes for patients. The PQI will educate oncologists and other members of the medically-integrated oncology pharmacy team who are involved in the care of oncology patients for whom Phexxi may be prescribed for hormone-free contraception.
Two posters on data sets from Evofem's Phase 3 AMPOWER trial evaluating Phexxi will be presented at the conference:
Sexual Satisfaction with Phexxi, a Hormone-Free Vaginal Contraceptive: Results from the AMPOWER Clinical Trial
Perfect–Use Pregnancy Rates with Phexxi, a Non-Hormonal Vaginal Contraceptive: Results from the Phase 3 AMPOWER Trial
"Female cancer patients can experience interruptions in their sex life while still maintaining a need for contraception," noted Brandi Howard, Ph.D., Evofem Biosciences' Head of Medical Affairs. "These data present relevant aspects of the AMPOWER trial that will be important for oncology professionals and their female patients to consider as they evaluate which hormone-free prescription contraceptive meets her needs before, during and after her cancer treatment regimen."
The posters will be available following the conference at https://www.evofem.com/posters-and-publications/. These data sets were previously presented at the ACOG 2020 Virtual Conference with abstracts published in the May 2020 issue of Obstetrics & Gynecology (The Green Journal) (May 2020, Vol 135).
Every year in the United States, more than 800,000 new cases of cancer are reported among women.1 Many cancer treatment protocols require female patients of reproductive age to use birth control while undergoing treatment. Non-hormonal prescription contraception options are starkly limited; previously, women were generally steered toward condoms or the copper IUD, a prescription medical device that is implanted in the uterus where it releases copper ions and causes inflammation.
The collaboration between NCODA and Evofem launched in February 2021 to positively impact the quality of life for female patients living with, fighting and recovering from cancer by raising awareness about the importance and availability of Phexxi as a birth control option. They are working together to develop and share resources and educational information for the medically-integrated oncology pharmacy team to help support female cancer patients in deciding which contraceptive option best meets each woman's unique, individual needs.
About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) is a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (STIs). The Company launched its first FDA-approved commercial product, Phexxi® contraceptive vaginal gel, in the United States in September 2020. The Company's lead product candidate, EVO100, is being evaluated for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection in women in the ongoing Phase 3 clinical trial, 'EVOGUARD.' For more information, please visit www.evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
About the AMPOWER Trial
AMPOWER was a single-arm, open-label Phase 3 study designed to evaluate the efficacy and safety of Phexxi® (lactic acid, citric acid and potassium bitartrate) in preventing pregnancy. The study enrolled 1,384 women aged 18-35 years across 112 centers in the United States. AMPOWER is the only large-scale, Phase 3 contraceptive clinical trial to evaluate the effects of a contraceptive product candidate on the impact of women's sex lives (exploratory endpoint).
Phexxi® is an on-demand method of birth control used to prevent pregnancy. Phexxi® is not effective when used after sex.
IMPORTANT SAFETY INFORMATION
Rare cases (0.36%) of bladder and kidney infection have been reported. If you have a history of urinary tract problems that keep coming back, you should not use Phexxi®.
Contact your healthcare provider if you are experiencing genitourinary side effects such as vaginal burning, itching, discharge, genital discomfort (including in male partners), yeast infection, urinary tract infection or bacterial vaginosis.
Phexxi® does not protect against any sexually transmitted infections, including HIV.
For more information about Phexxi®, talk to your healthcare provider and see full Product Information.
Please report side effects by contacting Evofem Biosciences® toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Various factors could cause actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward- looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements, or that could impair the value of Evofem Biosciences' assets and business, are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 4, 2021. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. This press release contains statistical data provided by independent parties relating to disease incidence. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.
1. U.S. Cancer Statistics: Highlights from 2017 Incidence. U.S. Cancer Statistics Data Briefs, No. 17, June 2020. https://www.cdc.gov/cancer/uscs/about/data-briefs/no17-USCS-highlights-2017-incidence.htm
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