Alkermes, Inc.
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Inclusion Criteria: * Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion. * Subject will benefit from continued therapy with OLZ/SAM per clinical judgment. * Subject is able to be treated on an outpatient basis. * Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient. * Subject's parent(s)/l…
Olanzapine and Samidorphan fixed dose coated tablet taken once daily