Nuplazide was called a "breakthrough" and received an accelerated review approved by the Food and Drug Administration in 2016. The agency ruled that the potential benefit to a desperate patient population outweighed their risks and thus the market's only drug market was approved to combat hallucinations and delusions in Parkinson's patients.
The FDA declined to comment on the ISMP report, saying: "In general, the FDA does not comment on individual studies or reports, but rather evaluates them as part of the evidence to find a better one Understanding of a particular problem and support in our mission to protect public health. "
Acadia denied the findings of the ISMP report and called them" serious misstatements and guesses about the safety and efficacy of NUPLAZID. " The report did not allow a complete characterization of Nuplazid's benefit-risk profile.
ISMP said it stood by its full report and said it was "a scientific report based on published data, FDA documents and the experience of our team of experts … The source documents and information we provide provide ample support for our findings of fact and conclusions about the risks and benefits of drugs. "
Prior to the FDA launching this most recent security review, ISMP published a report on the FDA-related adverse events in 2017, stating that the agency's medical examiner was banned from doing so Year 2016 against the approval of the drug had recommended.
Following the September FDA's conclusion that no changes were needed and that Nuplazid's current label adequately describes the risks, the group reiterates that Nuplazid was over-approved by the federal government without sufficient evidence that its benefits outweigh the risks.
"The FDA should reassess whether this drug has benefits that outweigh its still poorly defined risks," the report said. "We continue to agree with the original medical review of [Nuplazid] recommended against approval."
In response to the ISMP report, Acadia cited the FDA's conclusion, including how the Nuplazid distribution system contributes to the high number of reports of death and others contributed to adverse events. The company told CNN that it should commit to "strict and continuous monitoring and reporting of safety".
Authors of the ISMP report found that deaths from non-nasal acid patients continued to be reported to the FDA and urged the agency to modernize its reporting system to better identify if deaths or adverse events are related to medications In the case of Nuplazid, ISMP said that the FDA security reviewers found that many of the death reports contained too little detail to determine if nubercidol was a factor – a problem that, according to the ISMP, is not just for nuplazide.
The FDA noted that the risks of nuplazide are already covered by the label of the drug, which contains a black box warning. However, the ISMP said it was concerned that this warning – which indicates "increased mortality in elderly patients with dementia-related psychosis" – is not clear.
Nuplazide is approved for the treatment of Parkinson's disease (PDP) only and is not approved for the treatment of dementia. However, the FDA has confirmed to CNN that this black box warning also applies to PDP patients, which means that they also have an increased risk of death.
"The FDA should revise the current – and misunderstood – Boxed Warning to clarify what it means: Treatment with [Nuplazid] could lead to a significantly increased risk of death – similar to other antipsychotic drugs in elderly patient populations used with psychosis, "says the ISMP report.
It was also recommended to go ahead with the label to specifically warn doctors not to prescribe the drug in combination with other antipsychotics that have been shown to double the risk of death in Parkinson's patients.
Acadia referred to an FDA statement in which the agency reminded physicians to be aware of the risks of using Nuplazide with other antipsychotics, and said in the same statement that they had "potentially prescribing patterns." , The company previously told CNN that patients, caregivers and prescribers must consider the label and black box warning of nuplazide in the context of each patient's "assessed benefit / risk and other factors" – including their age and severity ,
CNN has been heard by several family members who said the drug helped ease their relatives' hallucinations To curb obvious side effects, and several prescribers said they had no concerns about the drug and welcomed FDA-approved treatment option for such a difficult condition, others wondered if Nuplazid contributed to the demise or death of their family member or said the drug did not work.
The company cited in the FDA study Data showed that nearly half of the patients taking the drug since it was on the market had died or had discontinued Nuplazid, whether due to cost, efficacy, side effects, or other reasons within the first two months after taking it Medicines Acadia said that there are a variety of reasons why people sell a drug, including "those who are often unrelated to the drug."
The company noted that it is reviewing documents from the FDA's Department of Psychiatry Products, which states that "the death reporting rate relative to the total number of patients taking [Nuplazid] changes little with exposure time If [Nuplazid] a significant number of deaths, these deaths are more likely to occur and reported within the first weeks or months of use. "
The ISMP report said that its concerns over the effectiveness of the drug by this company data" strengthened "were. This indicates that the high dropout rate is due to patients who have left the drug because it did not work, not necessarily due to death. And the FDA previously told CNN that "the most likely reason for stopping was that they did not find it helpful."
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