|
 Nuplazid's benefits outweighed the risks, the panel said, after 12
members voted in favor of the treatment and two against.
Acadia's shares, which were halted for trading during market hours
on Tuesday, jumped 25 percent in extended trading.
Several panel members said that while the drug's efficacy was not as
robust as they would have liked, it was "certainly better than
nothing." They said Nuplazid addressed the lack of treatment options
for patients suffering from the condition.
According to the National Parkinson Foundation, about 1 million
people in the United States and 4-6 million people worldwide suffer
from Parkinson's disease, Acadia said in a statement.
Psychosis, characterized by hallucinations and delusions, occurs in
about 40 percent of patients, the company said.
Currently, there is no drug approved in the United States
specifically for psychosis linked to Parkinson's disease and common
antipsychotic treatments including Quetiapine, Clozapine,
Risperidone and Zyprexa are used for these patients.
However, these drugs offer limited effectiveness and they also carry
a black box warning, the strongest warning imposed by the FDA, for
increased mortality in elderly patients.
Nuplazid may also have to carry a black box warning, but this is
unlikely to affect its adoption, analysts have said.
[to top of second column] |
The FDA is not obligated to follow the panel's recommendations, but
it usually does. The health regulator is scheduled to decide on
Nuplazid by May 1.
FDA staff said on Friday that Nuplazid was effective, but raised
questions about whether the observed treatment effect was clinically
meaningful.
Acadia shares were trading at $29.81 after the bell. Up to Monday's
close, the stock had lost a third of its value this year.
(Reporting by Amrutha Penumudi and Natalie Grover in Bengaluru;
Editing by Kirti Pandey)
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