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Nuplazid was the first medication approved in the United States to treat hallucinations and delusions associated with Parkinson’s disease psychosis. Since its launch in 2016, Nuplazid has been linked to thousands of adverse events, including hundreds of deaths.

What is Nuplazid?

Nuplazid (pimavanserin) is marketed by California-based Acadia Pharmaceuticals.

Up to 50% of the 1 million Americans suffering from Parkinson’s disease will experience hallucinations and delusions at some point during the course of their disease. Nuplazid belongs to a class of drugs called atypical antipsychotics and works by blocking serotonin receptors in the brain. These receptors are believed to play a role in hallucinations and delusions.

The U.S. Food & Drug Administration (FDA) approved Nuplazid in April 2016, via its “Breakthrough Therapy Designation” program, which allows for expedited approval 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.”

Nuplazid’s approval was based on a single, 6-week study that involved only around 200 patients. The drug’s earlier clinical trials did not show any benefit in reducing hallucinations and delusions associated with Parkinson’s disease.

Nuplazid Side Effects and Adverse Events

Like other antipsychotics, the Nuplazid label includes a Black Box Warning – the FDA’s most serious safety notice – regarding an increased risk of death when used to treat elderly dementia patients.

Common Nuplazid side effects include:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Confusion
• Nausea
• Rapid weight gain
• Unusual weight gain or loss

According to data from the drug’s only positive clinical trial, patients treated with Nuplazid were twice as likely to die or suffer other serious adverse events compared to those prescribed a placebo.

A recent analysis conducted by the Institute for Safe Medication Practices (ISMP) indicated that Nuplazid had been cited in more than 2,200 FDA adverse event reports collected during the 12 months ending in March 2017. The most frequently reported Nuplazid side effects included:

• Hallucinations (487)
• Confused state (258)
• Deaths (244)
• Complaints that the Nuplazid was ineffective (333)

Nuplazid Side Effects Concerned FDA Reviewers

The FDA advisory committee charged with reviewing Nuplazid prior to its approval recommended the drug by a vote of 12-to-2. However, the physician heading the panel raised concerns about the rate of deaths and other adverse events observed in Nuplazid’s single positive clinical trial, indicating that he was not convinced that the drug’s benefits outweighed its risks.

Several other panel members who voted to approve the drug also expressed reservations, with one urging the FDA to conduct further studies of Nuplazid once it came on the market in order to better understand its safety profile.