"The U.S. Food and Drug Administration today approved Nuplazid pimavanserin tablets the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinsons disease. Hallucinations or delusions can occur in as many as  percent of patients with Parkinsons disease at some time during the course of their illness. People who experience them see or hear things that are not there hallucinations andor have false beliefs delusions. The hallucinations and delusions experienced with Parkinsons disease are serious symptoms and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves.   Hallucinations and delusions can be profoundly disturbing and disabling said Mitchell Mathis M.D. director of the Division of Psychiatry Products in the FDAs Center for Drug Evaluation and Research. Nuplazid represents an important treatment for people with Parkinsons disease who experience these symptoms. An estimated  Americans are diagnosed with Parkinsons disease each year according to the National Institutes of Health and about one million Americans have the condition. The neurological disorder typically occurs in people over age  when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth purposeful movement  like eating writing and shaving. Early symptoms of the disease are subtle and occur gradually. In some people Parkinsons disease progresses more quickly than in others. As the disease progresses the shaking or tremor which affects the majority of people with Parkinsons disease may begin to interfere with daily activities. Other symptoms may include depression and other emotional changes hallucinations and delusions difficulty in swallowing chewing and speaking urinary problems or constipation skin problems and sleep disruptions.  The effectiveness of Nuplazid was shown in a sixweek clinical trial of  participants. Nuplazid was shown to be superior to placebo in decreasing the frequency andor severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinsons disease. As with other atypical antipsychotic drugs Nuplazid has a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs to treat older people with dementiarelated psychosis. No drug in this class is approved to treat patients with dementiarelated psychosis. In clinical trials the most common side effects reported by participants taking Nuplazid were swelling usually of the ankles legs and feet due to the accumulation of excessive fluid in the tissue peripheral edema nausea and abnormal state of mind confused state. Nuplazid was granted breakthrough therapy designation http for the treatment of hallucinations and delusions associated with Parkinsons disease. Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The drug was also granted a priority review. The FDAs priority review http program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness for the treatment prevention or diagnosis of a serious condition. Nuplazid is marketed by Acadia Pharmaceuticals Inc. of San Diego California. The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products."