Concerns over Nuplazid, an atypical antipsychotic approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, were initially voiced in a CNN article in early April which reported that the drug had been associated with over 700 deaths since its launch in March 2017. The number was calculated using the Food and Drug Administration (FDA)’s Adverse Events Reporting System (FAERS) Public Dashboard.
In response to the CNN article, the FDA released a statement to the media saying that the reported cases typically involved older patients with advanced-stage Parkinson’s disease. These patients often had comorbid conditions and were taking concomitant drugs that could have put them at increased risk for serious side effects and even death.
As part of an ongoing surveillance of new drug products, Acadia collects and analyzes postmarketing events and submits them to the FDA; these events are then incorporated into the FDA’s FAERS database. In a press release, the Company writes:
Because Nuplizad is distributed through a specialty distribution channel, we have frequent (in most cases monthly) contact with patients and caregivers through our distribution partners. This increased interaction naturally results in dramatically higher adverse event collection and reporting compared to products without such a distribution method. Approximately 93% of the reported adverse events associated with Nuplizad are considered “solicited” due to this direct interaction with patients and caregivers, while only approximately 7% of these events are considered “spontaneous” reports, which are voluntary reports originating from consumers or healthcare professionals. In contrast, most other antipsychotics are distributed through retail channels, which rely almost entirely on “spontaneous” reporting. Consequently, only a small fraction of actual adverse events are collected for these drugs.
Since the approval of Nuplazid, Acadia has conducted 2 placebo-controlled trials in frail elderly patients with dementia (N=300). Results from these studies showed no difference in the number of deaths between the Nuplazid- and placebo-treated groups. In addition, new data from 2 studies involving Parkinson’s disease patients, presented at the American Academy of Neurology Annual Meeting, showed that treatment with Nuplazid was well-tolerated and effective in the majority of patients.
At this time, the FDA states that no specific safety issue has been identified that would warrant a change to the prescribing information for Nuplazid.
For more information visit acadia-pharm.com.