The FDA accepted Alkermes' re-submission of a new drug application for APKS 3831 to treat schizophrenia

Schizophrenia is a mental illness characterized by distortions in thinking, opinion, emotion, language, self-awareness and behavior.
bipolar disorder is derived from the extreme state of the mood disorder, which has both emotions or bipolar states - depression and mania.
about 4 percent of Americans have different degrees of bi-phase disorder.
rates are the same for men and women.
usually in their teens, 20s or 30s.
Pharmaceutical Company Alkermes announced today that the U.S. Food and Drug Administration (FDA) has confirmed that it has received a re-submission of the company's application for a new drug for APKS 3831 (olanzapine / samidorphan) (NDA) for the treatment of adults with schizophrenia and adults with schizophrenia type I bipolar disorder.
that alkermes will continue to work closely with the FDA and is committed to providing APKS 3831 to patients as soon as possible after completing its review of the APKS 3831 NDA.
APKS 3831 is a research, novel, daily oral atypical antipsychotic candidate for the treatment of patients with schizophrenia and bisychotic type I disorder.
APKS 3831 consists of samidorphan, a new molecular entity, which is co-crafted in a double-layer tablet with an established antipsychotic drug, olanzapine.