FDA Approves First Treatment for Parkinson's Disease Psychosis

The approval is based on results from a 6-week Phase 3 trial
The approval is based on results from a 6-week Phase 3 trial

Acadia announced that the Food and Drug Administration (FDA) has approved Nuplazid (pimavanserin) tablets for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Nuplazid is the first treatment to be approved for this indication.

“Hallucinations and delusions can be profoundly disturbing and disabling,” said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. “Nuplazid represents an important treatment for people with Parkinson's disease who experience these symptoms.”

Nuplazid, a novel selective serotonin inverse agonist (SSIA), works through a combination of inverse agonist and antagonist activity at the serotonin 5-HT2A receptors and to a lesser extent at the serotonin 5-HT2C receptors. This mechanism avoids activity at dopamine and other receptors commonly targeted by antipsychotics. It does not interfere with patients' dopaminergic therapy and thus does not impair motor function. 

"Through its novel and selective mechanism of action, Nuplazid is a breakthrough treatment that works in a whole new way - treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson's psychosis patients,” said Michael S. Okun, MD, Medical Director of The National Parkinson Foundation. 

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The approval of Nuplazid was supported by data from the 6-week, Phase 3 Study -020 and other supportive studies. In Study -020 (n=199), treatment with Nuplazid significantly reduced the frequency and severity of psychotic symptoms vs. placebo on the Scale for Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD) without worsening the primary motor symptoms of Parkinson's disease. Full findings from the study were published in The Lancet

In clinical trials, the most common side effects reported by patients taking Nuplazid were peripheral edema, nausea, and confused state.  As with other atypical antipsychotic drugs, Nuplazid has a Boxed Warning alerting about an increased risk of death associated with the use of these drugs to treat dementia-related psychosis.

Nuplazid received a Breakthrough Therapy designation for this condition in 2014 as well as the FDA's priority review. It will be available as 17mg strength tablets in 60-count bottles. Nuplazid is anticipated to launch in June 2016.

For more information call (844) 422-2342 or visit Nuplazid.com.

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