The U.S. FDA said it plans to review Acadia Pharmaceuticals’ Nuplazid, the only approved drug used to treat hallucinations and delusions associated with Parkinson’s disease.
Nuplazid was granted breakthrough therapy designation and approved by the FDA two years ago. The agency approved the drug based on the on evidence of benefit from a single clinical trial and evidence of side effects from a total of three trials.
According to a recent CNN investigative piece, since Nuplazid’s release, there have been more than 2,200 "adverse events" reported that are possibly linked to the medication — including confusion, increased hallucinations and death.
In response to questioning at a budget hearing last week, FDA Commissioner Scott Gottlieb told members of Congress that he would "take another look" at Nuplazid.
San Diego-based Acadia told CNN that they continue “vigoriously” monitor all adverse events and that the benefit/risk profile of Nuplazid remains unchanged. The drugmaker pointed out that
Parkinson's disease is more typically seen in elderly patients with numerous medical comorbidities (simultaneous presence of more than one chronic disease or condition) and with an overall high risk of morbidity and mortality.