Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S have a definitive first-mover advantage with Rexulti (brexpiprazole) becoming the first drug to receive US Food and Drug Administration approval for agitation associated with dementia due to Alzheimer’s disease (AAD). They face potential competition in the form of Axsome Therapeutics, Inc.’s AXS-05 (dextromethorphan-bupropion), but with that drug’s Phase III study expected to complete in the first half of next year, Otsuka/Lundbeck have time to establish Rexulti.
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