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Alkermes Plc gets a boost as FDA approves its injectable schizophrenia drug

ARISTADA INITIO is expected to hit the market later this month
Needle
Alkermes shares are up nearly 7% in pre-market trade on the news

Alkermes Plc (NASDAQ:ALKS) reported a dose of good news, with today’s announcement that the US Food and Drug Administration has given the go-ahead and approved ARISTADA INITIO, its long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults.

ARISTADA INITIO (aripiprazole lauroxil), which is taken with a single 30mg dose of oral aripiprazole, is expected to hit the market this month.

“The approval of ARISTADA INITIO makes ARISTADA the first and only long-acting atypical antipsychotic that can be initiated on day one, representing an important addition to the treatment paradigm for the complex illness of schizophrenia,” said Dr. David Walling, chief executive and principal investigator of the Collaborative Neuroscience Network.

“For physicians and caregivers alike, the ARISTADA INITIO regimen provides a level of confidence that patients can walk out the door with up to two months of coverage with a proven medication in their system,” Walling added.

Schizophrenia is a chronic and disabling disorder, which involves hallucinations, delusions, depression and social withdrawal. As many as 2.4mln American adults have schizophrenia.

Alkermes shares climbed 6.85% to US$43.98 on the announcement of the drug’s approval.

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