(Corrects to remove paragraphs referring to Alzheimer's
disease. Alkermes' drug is not used to treat Alzheimer's)
April 8 Alkermes Plc said its
experimental drug to treat the symptoms of schizophrenia met the
main goal of reducing the severity of symptoms of the disease in
a late-stage study.
The company said it planned to submit a marketing approval
application for the drug, aripiprazole lauroxil, to the U.S.
Food and Drug Administration in the third quarter of 2014.
Alkermes' study tested patients injected with two doses of
the drug monthly for 12 weeks against patients given a placebo.
Aripiprazole lauroxil is an injectable long-acting version
of an antipsychotic and is being developed to be dosed once
every month or every two months.
Once inside the body, the drug converts into aripiprazole, a
blockbuster marketed as Abilify by Otsuka Pharmaceutical Co Ltd
. Alkermes' technology allows the drug to be released at
a controlled rate in the body, allowing patients to take the
drug less frequently.
The company said on Tuesday the drug was generally well
tolerated by the 623 patients enrolled in the study. The most
common adverse events were insomnia, headache and akathisia, a
condition characterized by uncontrollable restlessness.
Alkermes said all participants in the study were eligible to
continue in treatment for 12 months to monitor the safety and
long-term durability of the treatment.
Alkermes shares closed at $41.10 Monday on the Nasdaq.
(Reporting by Vrinda Manocha in Bangalore; Editing by Savio