San Diego's Acadia Pharmaceuticals Parkinson's disease drug offers more benefits than risks and no new safety concerns, the US Food and Drug Administration said Thursday.
Acadia shares closed Thursday at $ 19.11, up $ 4.01, or 26.5%, from Wednesday's close.
The drug, Nuplazid, treats the psychosis of Parkinson's disease, which causes mental disorders such as hallucinations and delusions. It affects about 40% of patients and occurs at later stages of the neurodegenerative disease.
The FDA has taken a closer look at Nuplazid after reports in April about Nuplazid's complications. The drug remained on the market while the FDA considered the concerns.
In the April reports, Nuplazid was associated with high rates of injury, including deaths, falls, insomnia, nausea and fatigue. Acadia said the claims were very overrated and risks were already stated in the "black box" warning.
The FDA said Thursday that deaths in patients taking Nuplazid should be understood in the context of the disease.
"In assessing death reports, the FDA has considered that patients with Parkinson's disease psychosis, for whom Nuplazid is indicated, have a higher death rate because of their advanced age, advanced Parkinson's disease and of other medical conditions, "said the FDA in a report.
"In addition, Nuplazid is primarily distributed through a patient support program and a network of specialty pharmacies, which increases the likelihood of deaths being reported to the manufacturer."
Nuplazid was approved in 2016 as the first medicine to treat this disorder. As a condition of approval, the FDA required a "black box" indicating serious side effects, including confusion, water retention or edema, and an increase in the mortality rate among patients. patients taking antipsychotics.
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