The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of
multiple inhaled doses of Staccato Loxapine.
The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety
and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time
period. The study will be conducted in schizophrenic patients who are on chronic, stable
antipsychotic medication. Patients meeting entry criteria will be randomized to one of three
dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of
medications, safety, tolerability and pharmacokinetic assessments will be conducted at
serial time points.
Inclusion Criteria include:
1. Male and female subjects between the ages of 18 to 65 years, inclusive.
2. Subjects who are on stable, oral, chronic (>2 mos) antipsychotic medication regimen
and who are able to tolerate the rapid oral dose taper and substitution regimen.
Exclusion Criteria include:
1. Subjects who are currently treated with injectable depot neuroleptics within one dose
interval must be excluded.
2. Subjects who have received loxapine or amoxapine within the last 30 days must be
3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and
amoxapine) must be excluded.
4. Subjects with a history of movement disorders including Parkinson's disease or a
history of neuroleptic malignant syndrome must be excluded.
5. Subjects who have a history within the past year of drug or alcohol dependence or
abuse as defined by DSM-4 must be excluded.