FDA approves Pimavanserin, the first drug to treat Parkinson's disease-related hallucinations and delusions
Lilac garden
On April 29, the U.S. FDA approved Pimavanserin (Nuplazid) tablets, which is the first drug approved for the treatment of hallucinations and delusions associated with mental disorders in some Parkinson's disease patients.
At a certain time during the onset of Parkinson's disease, as many as 50% of patients will experience hallucinations or delusions. Patients with hallucinations or delusions will see or hear things that are not there (hallucinations) and/or have false beliefs (delusions). The hallucinations or delusions in Parkinson's disease are serious symptoms that can cause serious injury of thinking and mood disorders, so that patients with such symptoms may not get along well with their loved ones or be unable to treat themselves well.
"Hallucinations and delusions can cause serious disturbance and disability," said Mathis, MD, director of the Psychiatric Products Division of the FDA's Center for Drug Evaluation and Research. "For Parkinson's disease patients with these symptoms, Pimavanserin represents an important therapeutic drug."
According to data provided by the National Institutes of Health, an estimated 50,000 people in the United States will be diagnosed with Parkinson's disease each year, and approximately 1 million people will have this disease. This neurological disorder usually occurs in people over the age of 60, when the cells that produce dopamine in the brain are damaged or die. Dopamine helps to transmit signals between areas that produce smooth, purposeful movements (such as eating, writing, and shaving).
The early symptoms of Parkinson's disease are mild and occur gradually. In some people, Parkinson's disease progresses faster than others. As the disease progresses, the shaking (tremor) that affects most people with Parkinson's disease may begin to interfere with daily activities. Other symptoms may include depression and other mood changes; hallucinations and delusions; difficulty swallowing, chewing, and speaking; problems with urination or constipation; skin problems and sleep disturbances.
The effectiveness of Nuplazid was demonstrated in a 6-week clinical trial involving 199 subjects. Nuplazid was superior to placebo in reducing the frequency and/or severity of hallucinations and delusions, while the main motor symptoms of Parkinson's disease did not worsen.
Like other atypical antipsychotics, Nuplazid carries a black box warning to provide health care professionals that using these drugs to treat elderly patients with dementia-related psychosis increases the associated risk of death.
None of these drugs have been approved to treat patients with dementia-related psychosis. In clinical trials, the most common side effect reported by Nuplazid subjects is swelling, which usually occurs in the ankles, legs, and feet. This is caused by excessive fluid accumulation in the tissues (peripheral edema). Other side effects include nausea and Abnormal mental state (confused state).
Nuplazid was awarded breakthrough therapy qualification for the treatment of hallucinations and delusions related to Parkinson's disease. The breakthrough therapy qualification is designed to accelerate the development and review of drugs that are designed to treat serious illnesses and preliminary clinical evidence shows that the drug may prove a substantial improvement in a clinically important endpoint compared with existing drugs.
The drug was also granted priority review qualification. The FDA priority review qualification provides an accelerated review for drugs that provide significant improvements in the safety or effectiveness of treating, preventing, or diagnosing serious diseases.
Nuplazid is marketed by Acadia Pharmaceuticals in San Diego, California.
