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Currently, Nuplazid (pimavanserin), marketed by Acadia Pharmaceuticals Inc., is the only medication approved by the FDA to treat the hallucinations and mental delusions associated with Parkinson’s disease psychosis. The FDA is now taking another look at the drug, however, after receiving reports of serious adverse events, including life-threatening incidents, falls, and even deaths.

FDA Approves Nuplazid as “Breakthrough Therapy”

The FDA approved Nuplazid in 2016, so it hasn’t been on the market very long. In a press release announcing the approval, the FDA noted that hallucinations and delusions can occur in as many as 50- percent of patients with Parkinson’s. These symptoms can lead to impaired thinking and emotions that can be dangerous enough to prevent a person from taking care of themselves.

Nuplazid’s safety and efficacy were shown in a six-week clinical trial of nearly 200 participants. According to the results, the drug was superior to the placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of the disease. The FDA committee voted 12-2 in favor of approval. At the time, however, some of the members who voted in favor of approval expressed concern about whether the benefits truly outweighed the risks.

The drug was granted “breakthrough therapy designation,” meaning that it went through an expedited review because it was intended to treat a serious condition and preliminary evidence showed it could provide a substantial improvement over currently available therapies.

The FDA required that the drug be sold with a boxed warning—the most serious kind—alerting patients and healthcare professionals to an increased risk of death associated with Nuplazid in people with dementia-related psychosis.

ISMP Warns that Nuplazid “Might Do More Harm Than Good”

Shortly after the drug was released on the market, the manufacturer and the FDA started to receive reports of serious adverse events. According to CNN, in more than 1,000 of those reports, the patients continued to experience hallucinations even while taking the drug. In other reports, patients experienced insomnia, nausea, fatigue, falls, life-threatening events, and death.

In their November 2017 Quarter Watch report, the Institute for Safe Medicine Practices (ISMP) noted that between the product’s launch in 2016 and March 2017, there had been over 2,200 reports of adverse events related to Nuplazid, with the individuals dying in 244 of those reports. The ISMP stated that the drug was approved on “limited scientific evidence that its benefits outweighed its risks,” and that in some of the reports, the drug was making the psychosis worse.

The ISMP warned that though approved only for the treatment of patients with Parkinson’s disease, the drug is now being tested for use in other populations. They concluded that the adverse event drug reports reinforced concerns that Nuplazid “might do more harm than good.”

Current FDA data shows that since the ISMP’s report came out, the number of deaths associated with Nuplazid has climbed to 700. Drug-maker Acadia says the patients taking the drug are in the advanced stages of the disease, and thus are already at high risk of death.

On April 25, 2018, CNN reported that the FDA is now taking a second look at Nuplazid.

One Comment

  1. Gravatar for Stephani Vanderholm
    Stephani Vanderholm

    About 30 percent of psychosis is treatment resistant, so if your looking for a perfect medication, it hasn’t come to market yet.

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