FDA Expedites New Psychosis Treatment Developed by Scientific Council Member

Dr. Herbert Meltzer, Professor of Psychiatry at the Northwestern Feinberg School of Medicine, Expert on Schizophrenia
Herbert Meltzer, M.D.

Brain & Behavior Research Foundation Scientific Council Member and NARSAD Distinguished Investigator Grantee, Herbert Meltzer, M.D., recipient of the Foundation’s Lieber Prize for Outstanding Achievement in Schizophrenia Research, was instrumental in developing a new drug, pimavanserin, for the treatment of psychosis associated with Parkinson's disease. The US Food and Drug Administration (FDA), is expediting the approval of this innovative therapy, which could come as early as next year, because currently there are no approved treatments for this type of psychosis in the United States.

"This is a landmark study and will potentially bring a new treatment option to large numbers of individuals with psychotic-spectrum disorders," says Bryan Roth M.D., Ph.D., Michael Hooker Distinguished Professor of Pharmacology at the University of North Carolina School of Medicine. 
Parkinson's disease psychosis is a debilitating psychiatric condition that develops in almost 60 percent of patients with Parkinson's disease. Traditionally, physicians would address this disorder by prescribing drugs that target dopamine signalling, because excess dopamine is thought to exacerbate psychosis. However, such treatments can produce serious side effects and often worsen the symptoms of Parkinson's disease.
What makes this treatment so effective is the fact that it does not interfere with dopamine signalling, but instead selectively blocks serotonin signalling. Dr. Meltzer, Professor of Psychiatry at the Northwestern Feinberg School of Medicine, developed pimavanserin together with the California-based company ACADIA Pharmaceuticals. This milestone represents a culmination of 25 years of research that Dr. Meltzer has spent designing more effective and safer drugs for the treatment of psychosis, with support from the Brain & Behavior Research Foundation, private donors, as well as the National Institute of Mental Health and ACADIA. A pivotal phase 3 clinical study demonstrated pimavanserin's effectiveness against psychosis in patients with Parkinson's disease and a separate study from Dr. Meltzer and colleagues showed that this innovative therapy also enhanced treatment response with current second generation antipsychotic drugs in acutely psychotic patients with schizophrenia.
“This is the first major novel advancement in the treatment of psychosis in the last 25 years and can be expected to have a big impact shortly in the treatment of all types of psychosis, especially schizophrenia and psychotic mood disorders,” says Dr. Meltzer. It is extremely well tolerated, unlike other antipsychotic drugs used for Parkinson’s disease psychosis. Once this drug is approved, he expects it will be tested and used extensively to treat other forms of psychosis, including Alzheimer’s psychosis. “The FDA has taken the unprecedented step in this area to expedite the approval of this drug because it is first in its class for the treatment of Parkinson’s disease psychosis and there is no FDA-approved treatment for this debilitating condition which creates great suffering for patients and their caregivers. I believe it will be widely used within five years as augmentation for current antipsychotic medications to achieve full efficacy, perhaps more quickly, and with fewer side effects as I have already demonstrated for risperidone in a clinical trial and for all other atypical antipsychotic medications in basic research studies.”