Evoke's sole treat­ment fails to evoke the FDA's con­fi­dence, as agency re­jects Gi­moti af­ter flag­ging con­cerns last month

Hav­ing out­lined a list of lin­ger­ing con­cerns with Evoke Phar­ma’s mar­ket­ing ap­pli­ca­tion for its sole drug last month, the FDA so­lid­i­fied its dis­sent with an out­right re­jec­tion, the com­pa­ny re­vealed on Tues­day.

The treat­ment, Gi­moti, is an in­tranasal spray for­mu­la­tion of the FDA-ap­proved meto­clo­pramide de­signed to sur­mount the lim­i­ta­tions of oral ad­min­is­tra­tion in pa­tients ex­pe­ri­enc­ing di­a­bet­ic gas­tro­pare­sis — char­ac­ter­ized by slow or de­layed gas­tric emp­ty­ing — that can cause nau­sea, vom­it­ing, and ob­struc­tion in the stom­ach, thwart­ing drug ab­sorp­tion. The drug al­so specif­i­cal­ly tar­gets women, who are dis­pro­por­tion­ate­ly af­fect­ed by the con­di­tion.

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