For many Parkinson’s patients and family members who were desperate for relief from advanced stage symptoms, the FDA’s approval of medical drug Nuplazid®, the first drug approved for treatment of debilitating psychosis, delusions and hallucinations in Parkinson’s patients, came as potential relief. Within two years of its being on the market, however, there are reports that a staggering 700 deaths may be linked to the drug, among other adverse effects.
When the FDA approved Nuplazid in April 2016, it included a boxed warning on the drug’s label stating that it may increase chances of death in elderly patients with dementia-related psychosis. Concerns have been raised that any potential benefits of the drug do not appear to outweigh the risks.
Nuplazid (pimavanserin) Background
Roughly one million people suffer from Parkinson’s disease in the U.S., half of whom may experience hallucinations or delusions over the course of their illness, according to the FDA. Prior to Nuplazid’s approval in 2016, no remedy was available for patients in the U.S. who suffered from these advanced stage symptoms.
Nuplazid, manufactured by Acadia Pharmaceuticals Inc., was approved under an FDA program designated “Breakthrough Therapy” designed to expedite the development and review of drugs that are found to offer a substantial improvement over available treatments for serious conditions.
The FDA approved Nuplazid largely based on the results of a six-week clinical trial that involved 199 participants and claimed a decrease in “frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease.”
According to the FDA, the most common side effects reported during the clinical trial were:
Swelling of the ankles, legs and feet
Abnormal or confused state of mind
A study by the Institute for Safe Medication Practices, however, questioned the safety and efficacy of Nuplazid, claiming the FDA approved the drug based on the results of a single clinical trial, despite three previous trials that failed to show a benefit of the drug.