Policy & Regulation
Evofem Biosciences receives US Patent No.11,439,610 for Phexxi composition of matter
26 September 2022 -

Evofem Biosciences (OTCPK: EVFM), a US-based commercial-stage biopharmaceutical company, announced on Friday that it has received United States Patent No. 11,439,610 from the United States Patent and Trademark Office (USPTO) for the composition of matter of Phexxi (lactic acid, citric acid, potassium bitartrate).

The product, the first and only FDA-approved hormone-free, woman-controlled contraceptive gel, works by maintaining vaginal pH in the optimal range of 3.5 to 4.5, which is inhospitable to sperm, and certain bacterial and viral pathogens, including chlamydia and gonorrhoea.

Top-line data from EVOGUARD, Evofem's registrational Phase 3 clinical trial evaluating Phexxi for these two potential new indications, are expected in mid-October. Positive outcomes of the EVOGUARD trial would enable regulatory submissions and potential approval of Phexxi for prevention of chlamydia and gonorrhoea in 2023. There are currently no FDA-approved drug products to prevent these infections.



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