Ot­su­ka’s fixed-dose com­bo dis­ap­points in PhI­II tri­al for Alzheimer’s ag­i­ta­tion

Ot­su­ka has run in­to a set­back bring­ing a sec­ond treat­ment for ag­i­ta­tion as­so­ci­at­ed with Alzheimer’s de­men­tia to mar­ket, as its can­di­date flunked a Phase III study.

To­geth­er with its part­ner Lund­beck, Ot­su­ka won a land­mark FDA ap­proval last May for the an­tipsy­chot­ic Rex­ul­ti to treat the con­di­tion, which is thought to af­fect half of all Alzheimer’s pa­tients. But the new­er can­di­date, AVP-786, failed to beat place­bo on an as­sess­ment of ag­i­tat­ed be­hav­iors.

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