About Phexxi (lactic acid, citric acid and potassium bitartrate) Vaginal Gel
Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Limitations of Use
Phexxi is not effective for the prevention of pregnancy when administered after intercourse.
Warnings and Precautions
Few cases (0.36%) reported adverse reactions of cystitis, pyelonephritis and other upper urinary tract infection (UTI) have been reported in Phexxi clinical studies. Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of Phexxi in females of reproductive potential with history of recurrent urinary tract infection or urinary tract abnormalities.
Adverse Reactions
Most common adverse reactions (2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.
Patients should be counseled on the following: To contact and consult with their healthcare provider for severe or prolonged genital irritation or experiencing urinary tract symptoms.
To discontinue Phexxi if they develop a local hypersensitivity reaction.
That Phexxi does not protect against HIV infection (AIDS) or other sexually transmitted infections.
About
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 its burn rate and cash runway, the success and timing of the commercial launch of Phexxi, the success of the Phexxi Concierge Experience, the execution and success of our publication and presentation plan, and the timing of our Phase 3 clinical trial for EVO100. 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
Contact:
Tel: (858) 550-1900
Email: araskopf@evofem.com
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