Acadia Hits 4-Year Low After CNN Reports Concerns on Key DrugBy and
Nuplazid named in hundreds of adverse event reports: CNN
Shares drop as much as 26% to lowest since April 2014
Acadia Pharmaceuticals Inc. shares tumbled to their lowest level in four years after a CNN report raised questions about whether its lead treatment played a role in the deaths of already sick and elderly patients.
CNN cited an analysis by a nonprofit health-care organization that found 244 deaths involving patients on Nuplazid, which treats hallucinations and psychosis associated with Parkinson’s disease, in the first nine months after its 2016 introduction. The drug was also named in several hundred “adverse events reports” -- which include side effects and other issues -- to the U.S. Food and Drug Administration, CNN reported Monday.
Acadia didn’t return calls seeking comment. Responding to CNN, the company said psychosis is more often seen in patients with advanced-stage Parkinson’s disease who are already at a high risk of death, and that it carefully monitors safety reports.
Shares of the San Diego-based drugmaker fell as much as 26 percent to $15.90, the lowest intraday price since April 2014, and traded at $16.33 as of 12:02 p.m. in New York.
The FDA said on Monday that Nuplazid carries a black box warning about potential risks, including an increased risk of death for patients with dementia-related psychosis, and that the agency hasn’t identified other safety issues that aren’t already outlined in the label.
“We have noted that the cases typically involve geriatric patients with advanced-stage Parkinson’s disease, as well as numerous medical conditions, who are frequently taking concomitant medications with risks for serious adverse events, including death," said Sandy Walsh, an FDA spokesperson.
An FDA advisory committee backed the drug in a 12-2 vote in March 2016, saying the benefits of the treatment outweighed the risk.
In October 2017, the drug was granted a “breakthrough therapy” designation for the treatment of dementia-related psychosis in patients with Alzheimer’s disease and Parkinson’s disease. The designation, intended to expedite drug development, is based on evidence suggesting that a medicine could bring substantial improvement over available treatments.
The company said in February that it expected the drug to bring as much as $270 million in sales this year. It’s the only drug approved by the FDA for the treatment of hallucinations and delusions in people with Parkinson’s disease-related psychosis, and is in late-stage trial to evaluate its treatment of persons with dementia-related psychosis.