Shares of Acadia Pharmaceuticals are down more than 18 percent in premarket trading following a CNN report that raises concerns over a number of deaths and adverse events linked to the company’s Parkinson’s disease drug Nuplazid.
Shares of Acadia Pharmaceuticals are down more than 18 percent in premarket trading following a CNN report that raises concerns over a number of deaths and adverse events linked to the company’s Parkinson’s disease drug Nuplazid.
Nuplazid, a selective serotonin inverse agonist that targets 5-HT2A receptors, was approved by the U.S. Food and Drug Administration in 2016 for hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid was the first drug of its kind for this indication. When it was approved Acadia estimated that approximately 40 percent of the four to six million people worldwide diagnosed with Parkinson’s suffer from Parkinson’s disease psychosis.
But this morning CNN’s report warns that Nuplazid may not be as safe as believed. In its report CNN said an analysis released by the nonprofit Institute for Safe Medication Practices indicated that 244 deaths had been reported to the FDA between the time Nuplazid became commercially available and March 2017. Not only did the nonprofit organization’s report link Nuplazid to the deaths, it also questioned its efficacy as a psychosis treatment.
The report actually gets worse for Acadia. CNN said since the initial analysis was released by the Institute for Safe Medication Practices the FDA’s own data shows the number of reported deaths that could be linked to Nuplazid has risen to more than 700.
“As of last June, Nuplazid was the only medication listed as ‘suspect’ in at least 500 of the death reports,” CNN said.
With the number of deaths that have been allegedly been linked to Nuplazid, CNN said some healthcare workers believe something “needs to be done to assess Nuplazid’s true risks.” To emphasize the concern Diana Zuckerman of the National Center for Health Research told CNN that the adverse event reports made to the FDA are voluntary, which means the number of deaths could actually be underreported.
“This is almost unheard of, to have this many deaths reported. You just don’t see this with most new drugs -- you don’t see all these reports -- so you have to take it seriously,” Zuckerman said.
Both San Diego-based Acadia Pharmaceuticals and the FDA maintain that the benefits of Nuplazid outweigh the risks, CNN said. In a response to CNN Acadia said there are several reasons that a high number of deaths could have been reported to the FDA. The company said Parkinson’s associated psychosis is most commonly seen in the late stages of the disease, which means they are at high risk of death. Acadia also noted that Nuplazid is prescribed through “a network of specialty pharmacies” that are closer to patient populations and maintains frequent contact with those patients and their caregivers. That means that those specialty pharmacies are likely to receive reports of deaths, which they are required to send on to the FDA.
Shares of Acadia are trading at $17.61 as of 9:58 a.m.
