The Food and Drug Administration today approved a New Drug Application (NDA) for the expanded use of Rexulti (brexpiprazole), already approved for schizophrenia, to treat agitation symptoms associated with dementia due to Alzheimer's disease (ALD).
People with ALD often have symptoms ranging from pacing or restlessness to verbal and physical aggression, according to Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
Often this is why people with ALD are then institutionalized or put in nursing homes for 100% care. Now with Rexulti approved for ALD, some may be able to avoid having to go to long-term care facilities.
Lundbeck, the Danish company behind Rexulti, along with its Japanese partner, Otsuka Pharmaceutical, Co. Ltd., said this is the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia and Alzheimer's.
The effectiveness of Rexulti for the treatment of agitation associated with dementia due to Alzheimer’s disease was determined through two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies.
In these studies, patients were required to have a probable diagnosis of Alzheimer’s dementia; have a score between 5 to 22 on the Mini-Mental State Examination, a test that detects whether a person is experiencing cognitive impairment; and exhibit the type, frequency, and severity of agitation behaviors that require medication. Trial participants ranged between 51 to 90 years of age.
Issues with the Study
Some have criticized the study as many of the test sites were based in Russia. Past studies had as many as 25% of their patients in Russian wards. This had been thought to increase the agitation levels of the patients. So the implication is that the drug's effectiveness could be seen as enhanced as any dial down in Russian ward patients aggressiveness would come from a high level.
However, there are now 2 million ALD patients in the U.S. Analysts expect that peak sales for the drug could reach $1 billion, which would also include its approval in use with patients with schizophrenia.
That also might have implications for the Lundbeck company which is publically traded in both Europe and in the U.S. (on the OTC market).
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