Evofem's ap­proved birth con­trol gel flops PhI­II for STI pre­ven­tion, ear­ly 2023 fil­ing plans ditched

A biotech with an ap­proved non-hor­mon­al birth con­trol gel had hoped it would be at the FDA’s doorsteps in ear­ly 2023 to re­quest a la­bel ex­pan­sion in­to STI pre­ven­tion.

But those am­bi­tions were squashed Wednes­day morn­ing as Evofem said its gel, mar­ket­ed as Phexxi for con­tra­cep­tive use, failed a Phase III study test­ing it as a way to stop the spread of chlamy­dia and gon­or­rhea in­fec­tion.

The com­pa­ny did not re­lease the topline da­ta. Asked for the da­ta, chief com­mer­cial of­fi­cer Kather­ine Atkin­son told End­points News in an emailed state­ment: “There was in­suf­fi­cient sep­a­ra­tion be­tween the ac­tive and the place­bo arm. A full re­port on the da­ta will be avail­able via the FDA in the near fu­ture.”

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