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UPDATE 1-Alexza says trial for acute agitation meets goal

Tue Dec 9, 2008 4:58pm EST

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Dec 9 (Reuters) - Alexza Pharmaceuticals Inc (ALXA.O) said AZ-004, its drug to treat acute agitation, met the main goal of a late-stage trial and that it expects to file for marketing approval in early 2010.

The company is developing AZ-004, an inhaled version of antipsychotic drug loxapine, to treat acute agitation in patients with schizophrenia or bipolar disorder.

Acute agitation can cause patients to become uncomfortable, tense and restless and if untreated, patients can become threatening and violent as the agitation intensifies, the company said.

Alexza said the trial met the main goal of reducing agitation in bipolar patients and with both doses of AZ-004, there was statistically significant reduction in agitation at the 2-hour post-dose time point, compared to placebo.

The drug was generally safe and well tolerated and there were no serious adverse events.

In September, the company said a late-stage trial of AZ-004 in schizophrenia patients also met the main goal.

The company's shares, which closed at $1.45 Tuesday on Nasdaq, were trading up at $1.60 after the bell. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Amitha Rajan)



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