Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.

This is a Phase 3, randomized, double-blind, placebo-controlled, in-patient, safety, and
efficacy study to evaluate HP-3070 for the treatment of schizophrenia.

This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo
transdermal patch in subjects diagnosed with schizophrenia, who are in an acute exacerbation
and to assess the impacts of covariates on asenapine exposure as delivered in a patch
formulation, using a population-based approach.

Inclusion Criteria:

- Current diagnosis of schizophrenia.

- Subject has PANSS total score ≥80, AND score of 4 or more in at least 2 of the
following PANSS items at Screening and at Baseline: conceptual disorganization
delusions; hallucinatory behavior; unusual thought content.

- Subjects must be able to wear a transdermal patch for 24 hours.

Exclusion Criteria:

- Subject has been diagnosed with schizophrenia less than 6 months prior to Screening
Visit.

- Subject has received within 90 days of Screening Visit: electroconvulsive therapy;
transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulation
treatments

- Subject has experienced acute depressive symptoms within 30 days prior to Screening
Visit that requires treatment with an antidepressant, as determined by the
Investigator.

- Currently taking clozapine for the treatment of schizophrenia.

- Has hypothyroidism or hyperthyroidism.

- Subject is currently being treated with insulin for diabetes.

- Subject has epilepsy or history of seizures.

- Positive urine pregnancy test.