Staccato Loxapine in Agitated Patients With Bipolar Disorder

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Patients With Bipolar I Disorder and Acute Agitation

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Inclusion Criteria:

• Male and female adult patients with bipolar 1 disorder and acute agitation

Exclusion Criteria:

• Agitation caused primarily by acute intoxication
• History of drug or alcohol dependence
• Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration