US Food and Drug Administration Extends Phexxi® Shelf Life to Four Years
Evofem Biosciences (Nasdaq: EVFM) announced that the FDA has extended the shelf life of its contraceptive Phexxi® from three to four years. This extension signals both the safety and high manufacturing standards of the product. The previous shelf life was 30 months, later increased to 36 months in April 2022, and now to 48 months with the latest FDA approval. The company is also expecting to release Phase 3 trial data for EVO100, Phexxi's investigational name, later this year, concerning its effectiveness in preventing sexually transmitted infections.
- FDA extended Phexxi's shelf life from three to four years, enhancing operational efficiency.
- The extension supports better inventory management in the U.S. market.
- Upcoming Phase 3 data for EVO100 may open new indications for preventing STIs.
- None.
SAN DIEGO, June 2, 2022 /PRNewswire/ -- Evofem Biosciences, Inc. (Nasdaq: EVFM) (Evofem) today announced that the U.S. Food and Drug Administration (FDA) has formally extended the shelf life of Phexxi® (lactic acid, citric acid, potassium bitartrate) from three to four years.
"The FDA's approval to extend Phexxi's shelf life to four years speaks not only to the safety of our ingredients but also to the exceptional standards applied in the manufacturing of Phexxi," said Saundra Pelletier, Chief Executive Officer at Evofem. "As we continue our long-term strategy to reduce operating expenses, this shelf life extension provides a significant and valuable operational efficiency, solidifying our ability to manage inventory within the growing US market and as we evaluate our strategic opportunities for the global licensing of Phexxi."
In May of 2020, the FDA approved Phexxi for the prevention of pregnancy. The 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 formally approved Evofem's 'Prior Approval' supplement for the shelf-life extension to 48 months.
Later this year, Evofem expects to readout top-line, Phase 3 registrational data from the EVOGUARD clinical trial investigating EVO100 (the investigational name for Phexxi) for the prevention of chlamydia and gonorrhea in women, two potential new indications.
Phexxi® is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex.
- 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 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 sexually transmitted infections, including HIV.
For more information about Phexxi, talk to your healthcare provider and see full Product Information at www.phexxi.com.
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.
Intended for United States residents only.
Evofem Biosciences, Inc. (Nasdaq: EVFM) is 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 chlamydia and gonorrhea. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
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, including, without limitation, 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, 2021, filed with the SEC on March 10, 2022. 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.
Media Contact
Jack Hirschfield
Evofem Biosciences, Inc.
jhirschfield@evofem.com
(512) 674-5163
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
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SOURCE Evofem Biosciences, Inc.
FAQ
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