Content about Alexza Pharmaceuticals

June 22, 2012
Alexza resubmits Adasuve for regulatory review

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

MOUNTAIN VIEW, Calif. — A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Alexza Pharmaceuticals said it received a complete response letter for Adasuve last month from the regulatory agency. The CRL outlined the FDA's concerns about Alexza's manufacturing facility and the drug's draft product labeling. Alexza said it believes it has addressed these concerns in its resubmitted application.

December 14, 2011
FDA advisory committee recommends approval for schizophrenia, bipolar disorder drug

A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

MOUNTAIN VIEW, Calif. — A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

January 24, 2011
In study, Alexza's schizophrenia treatment significantly improves symptoms

An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

MOUNTAIN VIEW, Calif. — An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

Alexza Pharmaceuticals announced results of a phase-3 trial of the inhaled drug AZ-004 (loxapine), which showed statistically significant improvement in symptoms of agitation in patients compared with the placebo.

February 21, 2010
Alexza Pharmaceuticals promotes Mark Oki to VP finance

Alexza Pharmaceuticals has promoted controller and director Mark Oki to controller and VP finance, the...

February 9, 2010
Biovail, Alexza develop inhaled mental health treatment

An inhaled mental health drug could appear on the market in the near future under...