CORRECTED-UPDATE 1-Alkermes' schizophrenia drug meets main goal of late-stage study

Tue Apr 8, 2014 10:53am EDT

(Corrects to remove paragraphs referring to Alzheimer's disease. Alkermes' drug is not used to treat Alzheimer's)

April 8 (Reuters) - 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 D'Souza)

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