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Evofem drug receives US FDA's fast-track designation

Evofem Biosciences Inc. secured the U.S. Food and Drug Administration's fast-track designation to expedite the development of its drug Amphora.

Amphora is being investigated as a treatment of one of the most commonly reported sexually transmitted infections in women in the U.S., urogenital chlamydia.

Approximately 1.6 million new cases of the infection were reported in 2016 alone, an increase of 4.7% from the prior year, Evofem said in a statement.

While treatment with antibiotics is effective, repeat infection is common, and multiple chlamydial infections can increase a woman's risk of reproductive health complications, including pelvic inflammatory disease and ectopic pregnancy.

Amphora is going to be studied in a phase 2b/3 study to evaluate its effectiveness. The fast-track designation will help facilitate development by allowing the company to have more frequent meetings with the FDA to discuss the drug's development plan and ensure that the appropriate data needed to support approval is collected.

San Diego-based Evofem is also developing Amphora as a vaginal contraceptive and will release the results of a late-stage trial evaluating the medicine for that purpose in the first quarter of 2019.