Prob­lems, prob­lems, prob­lems: But Alk­er­mes will fight it out this week over the FDA’s ob­jec­tions to its big de­pres­sion drug ALKS 5461

Alk­er­mes tried sev­er­al new things when their re­searchers test­ed ALKS 5461 for ma­jor de­pres­sion in clin­i­cal tri­als. Now they have to see if they can con­vince the FDA and a group of out­side ex­perts that the drug is ac­tu­al­ly as ef­fec­tive — and as safe — as they in­sist it is.

Alk­er­mes $ALKS is at­tempt­ing to gain an ap­proval for this drug — which is seen as a lynch pin to its fu­ture rev­enue — de­spite key tri­al fail­ures and an ar­guably thin lay­er of con­tro­ver­sial da­ta back­ing the drug.

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