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ADASUVE Inhalation Powder Alexza Pharmaceuticals, Inc.

Generic Name: loxapine
Date of Approval: December 21, 2012
Company: Alexza Pharmaceuticals, Inc.
Detail-U.S. FDA Approves Alexza's ADASUVE® (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults
MOUNTAIN VIEW, Calif., Dec. 21, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food and Drug Administration (FDA) approved ADASUVE® (loxapine) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. ADASUVE combines Alexza's proprietary Staccato® delivery system with the antipsychotic drug, loxapine. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption of a drug. See below for Important Safety Information about ADASUVE, including Boxed Warnings.

"The approval of ADASUVE is an important event in the treatment of agitation. ADASUVE is the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder. As noted in the consensus guidelines for Best Practices in the Evaluation and Treatment of Agitation, we believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them," said Thomas B. King, President and CEO of Alexza. "This is a landmark day for Alexza and we are proud of our accomplishments in developing this unique product. We project that ADASUVE will be available for commercial launch early in the third quarter of 2013."
INDICATIONS AND USAGE

ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.
Limitations of Use: ADASUVE must be administered only in an enrolled healthcare facility.

IMPORTANT SAFETY INFORMATION

WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.

Bronchospasm:

ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest
ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation)
Increased Mortality in Elderly Patients with Dementia-Related Psychosis:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis
CONTRAINDICATIONS:

ADASUVE is contraindicated in patients with the following:

Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung disease associated with bronchospasm
Acute respiratory signs / symptoms (e.g., wheezing)
Current use of medications to treat airways disease, such as asthma or COPD
History of bronchospasm following ADASUVE treatment
Known hypersensitivity to loxapine and amoxapine
WARNINGS AND PRECAUTIONS:

Neuroleptic Malignant Syndrome: May develop in patients treated with antipsychotic drugs. Discontinue treatment
Hypotension and Syncope: Use with caution in patients with known cardiovascular or cerebrovascular disease
Seizure: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold
Potential for Cognitive and Motor Impairment: Use caution when driving or operating machinery
Cerebrovascular Adverse Reactions: Increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis treated with antipsychotic dru

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