A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection

This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).

Inclusion Criteria:

• Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole
• Has a diagnosis of schizophrenia
• Is clinically stable
• Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.
• Has no antipsychotic medication regimen change for 4 weeks prior to Day 1
• Agreed to abide by the contraceptive requirements o the protocol
• Resides in a stable living situation
• Additional criteria may apply

Exclusion Criteria:

• Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
• Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening
• Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product
• Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening
• Additional criteria may apply