During the early clinical trials of a new Parkinson's treatment drug, Nuplazid® (pimavanserin) showed promise. Still, many doctors and physicians were cautious about the potential harmful effects that began to show up during the trials. The drug was awarded expedited approval in spite of the concerns. However, by March of last year, 244 deaths were reported in FDA adverse event reports involving Nuplazid.
Treating Parkinson's Psychosis
San Diego's Acadia Pharmaceuticals developed Nuplazid as a medication for treating psychosis among those with Parkinson's disease. Parkinson's is a degenerative disease involving the central nervous system that hinders movement, balance, causes tremors, and other impairments.
For those with Parkinson's disease who experience psychosis, it can be terrifying and debilitating. Sufferers may experience hallucinations, paranoia, and other psychotic-type events. Approximately half of those with Parkinson's disease experience psychosis, which is most common among those where the disease has progressed significantly.
Breakthrough Drug Fast-Tracked Approval
In 2012, facing criticism about the slow-moving approval process, the FDA began expediting certain medications. Congress approved the "breakthrough therapy” designation for drugs that demonstrated “substantial improvement” in serious or life-threatening conditions, including diseases like Parkinson's. Among the drugs to receive this expedited designation was Nuplazid. However, even at those stages before approval, some were worried about the possible side effects of the drug.
The drug still had to meet the advisory committee's approval that the benefits of the drug outweighed the risks. However, even during the clinical trial phase, some on the review committee were wary about the risks of the drug.
Dr. Paul Andreason, a physician who was part of the medical review, was concerned about the serious risks associated with the drug. Serious events, including death, were showing up at much higher rates in the clinical trial as compared with those in the placebo group. Dr. Andreason thought more time and more testing was needed to properly evaluate the drug and its potentially harmful effects.
More than 1,000 adverse event reports have been documented involving Nuplazid. The Institute for Safe Medication Practices stated that 244 fatalities were reported prior to March of 2017. Since the report, the number of adverse event reports involving death has increased to over 700 and continue to come in.
Other serious adverse events have included reported falls, insomnia, nausea, and fatigue. In many other patients, the so-called “breakthrough drug” has shown no improvement in their Parkinson's-related hallucinations.
Drug Company's Financial Stake
Acadia Pharmaceuticals Inc. is the manufacturer and is traded on NASDAQ. After the Institute for Safe Medication Practices released their report about Nuplazid, their stock price plummeted by over 20%. Acadia previously reported product sales of $270 million.
The company remains optimistic that sales will grow, despite still recovering from the negative publicity surrounding the risk of death associated with Nuplazid. The company stated that the risk/benefit analysis of Nuplazid has not changed since the adverse events reporting.
Continuing Reports of Deaths
According to Diana Zuckerman of the National Center for Health Research, this many reported deaths involving a single drug is “almost unheard of.” The growing reports of death may be seen as a warning signal of the drug's more wide-spread potential for harm. As more information is coming in, some professionals have indicated the product may be doing more harm than good. For patients and family members dealing with the disease, the promise of a “breakthrough” drug carries the risk of death even for those where the drug offered no relief from the pain of Parkinson's-related psychosis.