Staccato Loxapine in Agitation (Proof of Concept)

Inclusion Criteria:

1. Male and female patients between the ages of 18 to 65 years, inclusive.

2. Patients who have met DSM-IV criteria for schizophrenia, schizophreniform disorder, or
schizoaffective disorder.

3. Patients who are judged to be clinically agitated at Baseline with a total score of ≥
14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and
excitement) comprising the PANSS Excited Component (PEC).

4. Patients who have a value of ≥ 4 (out of 7) on at least 1 of the 5 items on the PANSS
Excited Component.

5. Patients who read and understand English and provide written informed consent.

6. Patients who are in good general health prior to study participation as determined by
a detailed medical history, physical examination, 12-lead ECG, blood chemistry
profile, hematology, urinalysis and in the opinion of the Principal Investigator.

7. Female participants, if of child-bearing potential and sexually active, and male
participants, if sexually active with a partner of child-bearing potential, who agree
to use a medically acceptable and effective birth control method throughout the study
and for one week following the end of the study. Medically acceptable methods of
contraception that may be used by the participant and/or his/her partner include
abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine
device (IUD), condom with foam or spermicide, vaginal spermicidal suppository,
surgical sterilization and progestin implant or injection. Prohibited methods include:
the rhythm method, withdrawal, condoms alone, or diaphragm alone.

Exclusion Criteria:

1. Patients with agitation caused by acute intoxication must be excluded. Positive
identification of non-prescription drugs during urine screening excludes the subject.

2. Patients treated with benzodiazepines or other hypnotics or oral or short-acting
intramuscular antipsychotics within 4 hours prior to study drug administration must be
excluded.

3. Patients treated with injectable depot neuroleptics within one dose interval prior to
study drug administration must be excluded.

4. Patients with a history of allergic reactions to loxapine or amoxapine must be
excluded.

5. Female patients who have a positive pregnancy test at screening or are breastfeeding
must be excluded.

6. Patients who have Parkinson's disease, hydrocephalus, seizure disorder, or history of
significant head trauma must be excluded.

7. Patients with laboratory or ECG abnormalities considered clinically significant by the
investigator or qualified designee that would have clinical implications for the
patient's participation in the study must be excluded.

8. Patients with serious and unstable illnesses including current hepatic, renal,
gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and
congestive heart failure), endocrinologic, neurologic (including stroke, transient
ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and
meningitis), or hematologic disease must be excluded.

9. Patients who have a history of acute or chronic pulmonary disease that precludes
administration of Staccato Loxapine (asthma, bronchitis, emphysema) must be excluded.

10. Patients who have received an investigational drug within 30 days prior to the current
agitation episode must be excluded.

11. Patients who are considered by the investigator, for any reason, to be an unsuitable
candidate for receiving loxapine, or unable to use the inhalation device, must be
excluded.