Bipolar disorder (formerly known as manic depression) is characterized by depression alternating with mania, or mild mania.
mania is mainly manifested in excessive activity and non-conformity with the outside world of high mood.
usually in their teens, twenties or thirties.
pharmaceutical company Alkermes announced today that the U.S. Food and Drug Administration's (FDA) Advisory Committee on Psychopharmaceuticals and the Advisory Committee on Drug Safety and Risk Management voted in favour of APKS 3831 (Otoxepine/Shamedofen) for the treatment of schizophrenia and biphasia.
APKS 3831 is a new oral atypical antipsychotic candidate.
FDA Committee found that shamedofen in ALKS 3831 was effective in reducing the weight gain associated with oxycoddm, and that the safety of ALKS 3831 had been fully demonstrated.
. Craig Hopkinson, Chief Medical Officer and Executive Vice President of Research and Development at
Alkermes, said, "Today's outcome is a milestone for patients with schizophrenia and biplex disorder, clinicians, and patient families.
We look forward to working with the FDA to complete a follow-up review of the drug."