SAN DIEGO, Sept. 8, 2020 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that Phexxi™ (lactic acid, citric acid and potassium bitartrate), the first and only non-hormonal prescription vaginal gel is now available in the United States for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Approved by the U.S. Food and Drug Administration (FDA) on May 22, 2020, Phexxi is a vaginal pH modulator designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm. Phexxi will be commercially available in a box containing 12 individually wrapped Phexxi applicators. For more information, visit www.phexxi.com.
"As a leader of innovation in women's healthcare, we are thrilled to usher in a new era of sexual and reproductive health with the launch of Phexxi," said Saundra Pelletier, Evofem Biosciences' Chief Executive Officer. "Millions of women have either settled for less or completely opted out of using birth control because they have had enough with side effects and lack of control. Today, we are fulfilling Evofem's mission of delivering a novel contraceptive option that women have been waiting for."
Evofem is also launching the Phexxi Concierge Experience, a comprehensive woman-centric telemedicine support system to help ensure Phexxi is accessible to all women who need it. This robust offering of services is designed to help women quickly consult with a healthcare provider to secure a Phexxi prescription, determine their insurance coverage and/or out-of-pocket costs, receive counseling support and refill reminders, and fill their prescription through their local neighborhood pharmacy or our mail order pharmacy partner, KnippeRx, that is expected to deliver Phexxi right to their door.
Evofem is committed to facilitating access to Phexxi for women who are not covered by government or private health plans and will provide a financial assistance program to enable access to Phexxi for eligible women. Through this program, eligible patients may pay a $0 co-pay for their first prescription of Phexxi, and as little as $30 on future prescriptions.
ABOUT PHEXXI™ (lactic acid, citric acid and potassium bitartrate) VAGINAL GEL 1.8%, 1%, 0.4% Phexxi is a prescription vaginal gel used to prevent pregnancy in females who choose to use an on-demand method of birth control.
LIMITATIONS OF USE Phexxi is not effective for the prevention of pregnancy when administered after intercourse.
IMPORTANT SAFETY INFORMATION What are the possible side effects of Phexxi? There have been a few cases of urinary bladder infection and kidney infection reported in clinical studies. One of the cases was serious. Avoid Phexxi if you have had repeated urinary tract infections or other urinary tract problems.
The most common side effects were vaginal burning, vaginal itching, vaginal yeast infection, urinary tract infection, vaginal area discomfort, bacterial vaginosis, and vaginal discharge. Women also reported genital discomfort, pain while urinating, and vaginal pain. Some male partners reported genital discomfort.
What else should I know about using Phexxi? Phexxi does not protect against any sexually transmitted diseases, including HIV. Avoid using Phexxi with a vaginal ring.
Contact your healthcare provider if you are experiencing severe genital irritation or discomfort or urinary tract symptoms. Avoid Phexxi if you or your sexual partner is allergic to lactic acid, citric acid, potassium bitartrate, or any of the ingredients in Phexxi. Stop using Phexxi if you develop an allergic reaction.
Full Prescribing Information for Phexxi is available at Phexxi.com.
To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Evofem Biosciences, Inc. 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's first commercial product, Phexxi™ (lactic acid, citric acid and potassium bitartrate), is the first and only hormone-free, prescription vaginal gel approved in the United States for the prevention of pregnancy. The Company is also advancing EVO100 into Phase 3 clinical trials for the prevention of urogenital transmission of both Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women. For more information, please visit www.evofem.com.
Phexxi™ is a trademark of Evofem Biosciences, Inc.
Forward-Looking Statements 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, including, without limitation, statements related to Evofem's expectations regarding the success of the commercial launch of Phexxi, the success of the Phexxi Concierge Experience, our ability to obtain coverage under the ACA and the copay assistance program. 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 Evofem's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 12, 2020, its Quarterly Report on Form 10-Q for the quarter ended March 31 filed with the SEC on May 6, 2020 and August 4, 2020, and its Current Report on Form 8-K filed with the SEC on June 2, 2020. All forward-looking statements are expressly qualified in their entirety by such factors. Evofem does not undertake any duty to update any forward-looking statement except as required by law.