FDA Committee Members Concerned Drug Was Unsafe Before Approval A recent news report by CNN raises issues concerning a Parkinson’s disease drug. The drug was approved for market in an expedited fashion and has now been linked to worsening symptoms and a large number of deaths in patients. Nuplazid Approved Through Shorter FDA Process An […]
A recent news report by CNN raises issues concerning a Parkinson’s disease drug. The drug was approved for market in an expedited fashion and has now been linked to worsening symptoms and a large number of deaths in patients.
An estimated 1 million people in the United States have Parkinson’s disease, and about half of these people struggle with a psychotic effect of the disease. People with Parkinson’s disease psychosis experience frightening hallucinations and delusions, often leading to paranoia and isolation. Many of them suffer from both visual and auditory hallucinations that can be utterly terrifying.
Until 2016, no drug had been approved to address this severe complication of Parkinsonism. In that year, however, Acadia Pharmaceuticals Inc., of San Diego, received approval by the U.S. Food and Drug Administration (FDA) to sell the drug Nuplazid. Nuplazid (pimavanserin) is the first atypical antipsychotic drug approved for treatment of hallucinations and delusions in patients with Parkinson’s disease psychosis.
The drug was approved through use of a specialized process for “breakthrough therapy.” If a drug has been associated with a significant improvement in patients with serious illnesses (compared to other drugs available), the FDA will sometimes allow it to gain approval through a rushed “breakthrough therapy” process. This process takes far less time than the usual channels of FDA approval.
In 2016, Acadia and several families affected by Parkinson’s disease psychosis advocated for Nuplazid’s expedited approval to an FDA advisory committee. In a 12 to 2 vote, the committee granted approval of the drug. The two members of the committee voted against approval were concerned about the drug’s safety after hearing warnings like that of the lead physician of the FDA medical review for Nuplazid, Dr. Paul Andreason.
Dr. Andreason indicated his findings showed the drug’s key clinical trial demonstrated little benefit in the way of hallucination control and exposed significant risks, including twice the number of patient deaths as in the placebo group. He also said the drug’s three previous trials yielded no perceived benefit to patients at all yet demonstrated the same risks.
Other members of the committee expressed reservations about the drug and wanted additional testing to be conducted but nevertheless voted to approve it.
Less than a year after the drug hit the market, the FDA and Acadia had received hundreds of adverse event reports regarding Nuplazid. Many patients reported the drug was not effective, and numerous patients reported the drug had actually worsened their hallucinations and delusions. Other patients reported complications like falls, insomnia, fatigue, nausea, and life-threatening incidents.
Most alarming, between the time Acadia began selling the drug, in June 2016, and March 2017, the FDA had received reports of 244 patient deaths. Since that time, the number of reported deaths in patients taking Nuplazid has almost tripled, growing to more than 700 people.
The Institute for Safe Medication Practices has reported that these adverse events “reinforce the concerns of those who warned that might do more harm than good.” In addition, the founder and president of the National Center for Health Research stated that the number of reported deaths was “almost unheard of” and needed to be taken seriously.
Nuplazid has not been found the definitive cause of death in these patients — patients who were, according to the FDA, predominantly elderly and suffering from numerous medical conditions that required other prescription medications. But Nuplazid is the only drug listed as “suspect” in 500 of the death reports.
In the wake of the adverse event reports regarding Nuplazid, the FDA and manufacturer Acadia are still taking the position that the drug’s therapeutic benefits outweigh its potential risks to patients. The FDA said it has not yet seen any reports that identified safety issues not already addressed in Nuplazid’s warning label.
Currently, Nuplazid’s label contains a “black box” warning, which is the strongest possible warning for prescription drug packaging and requires serious warning information to be encased in a bold black box at the top of the label. The black box on the Nuplazid label warns of increased risk of death in patients with dementia-related psychosis. Notably, Nuplazid is expressly not approved for patients with dementia-related psychosis that is not associated with Parkinsonism.
In explanation of the adverse event reports, Acadia released a statement in which it said the high number of deaths were likely due to the target patient population. These patients, the manufacturer said, were already at a high risk of dying due to the advanced stages of their Parkinson’s disease. Acadia also offered that these patients were buying their drugs from specialty pharmacies, which have more consistent contact with patients and were, therefore, more aware of patient deaths.
Additionally, Acadia cited to two newer studies conducted since the drug’s approval that did not find any increased deaths in patients taking Nuplazid compared to patients taking a placebo. Acadia maintains that patients taking Nuplazid have actually died at lower rates than the general population of Medicare patients with Parkinson’s disease psychosis. Experts interviewed by CNN disputed this finding.
Since news of Nuplazid patient deaths broke, Acadia’s stock dropped 20 percent. In 2017, the drug company saw approximately $125 million in Nuplazid sales, and it expected those sales to double in 2018. With a cost that can reach $100 a day, some individual Parkinson’s patients might pay up to $30,000 a year for the drug.
While keeping its eye on stock values and projected Nuplazid sales, Acadia is in the process of expanding the use of Nuplazid. The manufacturer is currently in the midst of another round of clinical trials aimed at approval for use in patients with dementia-related psychosis (the condition for which the drug label already contains a block box warning regarding increased risk of death). Currently, doctors can prescribe the drug for use in patients with dementia-related psychosis, but insurance companies are not likely to pay for drugs prescribed off-label, making the practice rare in medicine. To have the best chance of additional prescriptions, the manufacturer needs more FDA-approved uses. If approved for this new use, Nuplazid would reach a much wider net of patients, potentially rocketing its Nuplazid profits.
As of October 2017, the FDA had also designated Nuplazid a “breakthrough therapy” for dementia-related psychosis. This means Acadia will again benefit from a faster FDA approval process for its drug. Another committee will meet in the near future to determine for the second time whether Nuplazid shows significant improvement in patients and whether its benefits outweigh its risks. But this time, the committee members will have a lot more data in front of them.
The national product liability attorneys at Parker Waichman LLP are offering free, no-obligation case consultations regarding the filing of Nuplazid lawsuits. If you have been affected by complications from taking the Parkinson’s disease psychosis drug Nuplazid, contact our office today. We are available by phone at 1-800-YOURLAWYER (1-800-968-7529) and online through the contact form on our website.
