US Food and Drug Administration Extends Shelf Life of Phexxi® to Four Years

SAN DIEGO, June 2, 2022 /PRNewswire/ — Evofem Biosciences, Inc. (Nasdaq: EVFM) (Evofem) today announced that the U.S. Food and Drug Administration (FDA) has officially extended the shelf life of Phexxi® (lactic acid, citric acid, potassium bitartrate) from three to four years.

“FDA approval to extend the shelf life of Phexxi to four years is a testament not only to the safety of our ingredients, but also to the exceptional standards applied in the manufacturing of Phexxi,” said Saundra Pelletier, CEO of Evofem. “As we pursue our long-term strategy to reduce operating expenses, this shelf life extension provides significant and valuable operational efficiencies, bolstering our ability to manage inventory in the growing U.S. market and so that we are evaluating our strategic opportunities for the global licensing of Phexxi.”

In May 2020, the FDA approved Phexxi for pregnancy prevention. Initial approval included a 30-month shelf life for Phexxi, which was extended to 36 months in April 2022 by the FDA. Earlier this week, the FDA officially approved Evofem’s “Prior Approval” supplement for shelf-life extension to 48 months.

Later this year, Evofem plans to read Phase 3 registration data from the EVOGUARD clinical trial of EVO100 (the experimental name of Phexxi) for the prevention of chlamydia and gonorrhea in women, two potential new indications.

About Phexxi®

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 infections 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 experience 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 sexually transmitted infections, including HIV.

For more information about Phexxi, talk to your healthcare provider and see complete product information at www.phexxi.com.

Please report side effects by contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Intended for US residents only.

About Evofem Biosciences

Evofem Biosciences, Inc. (Nasdaq: EVFM) develops and markets innovative products to address the unmet sexual and reproductive health needs of women, including hormone-free, female-controlled contraception and protection against chlamydia and gonorrhea. The company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, prescription vaginal contraceptive gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each sexual intercourse. Learn more at phexxi.com and evofem.com.

Phexxi® is a registered trademark of Evofem Biosciences, Inc.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the safe harbor for forward-looking statements contemplated 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 any forward-looking statements, including, without limitation, and you are cautioned not to place undue reliance on such forward-looking statements, which are not day than on 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 adversely affect the value of the assets and businesses of Evofem Biosciences are disclosed in the documents filed by the Company. with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 10, 2022. All forward-looking statements are expressly qualified in their entirety by these factors. The Company undertakes no obligation to update forward-looking statements, except as required by law.

Media Contact
jack hirschfield
Evofem Biosciences, Inc.
[email protected]
(512) 674-5163

Investor Relations
Amy Raskopf
Evofem Biosciences, Inc.
[email protected]
(917) 673-5775

SOURCEEvofem Biosciences, Inc.

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