FDA mulls reg­u­la­to­ry ac­tion on Sprout's 'fe­male Vi­a­gra' af­ter ad­verse events spike

Be­fore there was Bio­gen’s Aduhelm, there was Sprout Phar­ma­ceu­ti­cals’ “fe­male Vi­a­gra” pill Ad­dyi. Both FDA-ap­proved drugs stirred up sig­nif­i­cant con­tro­ver­sy be­cause their ap­provals were based on lim­it­ed ef­fi­ca­cy da­ta and lin­ger­ing safe­ty con­cerns.

While Aduhelm is meant to ad­dress a sig­nif­i­cant un­met need in the Alzheimer’s space, Ad­dyi is de­signed for pre­menopausal women whose lack of sex­u­al de­sire caus­es dis­tress. In the clin­i­cal tri­al sup­port­ing its ap­proval, those who took Ad­dyi had an in­crease of about one sex­u­al­ly sat­is­fy­ing event per month ver­sus those giv­en place­bo.

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