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The FDA has accepted for review the New Drug Application (NDA) for ALKS 3831 (Alkermes) for the treatment of schizophrenia and bipolar I disorder.

ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

For patients receiving highly emetogenic chemotherapy who experience breakthrough chemotherapy-induced nausea and vomiting, treatment with olanzapine (Zyprexa) is significantly better than treatment with metoclopramide.

The researchers found that from baseline to week 12, the dual-energy X-ray absorptiometry percentage total body fat increased by 1.18, 4.12, and 1.66% for risperidone, olanzapine, and aripiprazole, respectively, and was significantly greater for olanzapine than risperidone or aripiprazole.

The review found no statistically significant difference between the two groups regarding adherence and treatment response.

Lybalvi is an atypical antipsychotic comprised of samidorphan co-formulated with olanzapine in a single bilayer tablet.

Teva announced the launch of Olanzapine and Fluoxetine HCl capsules, the generic version of Eli Lilly’s Symbyax capsules.

Mylan announced the launch of Olanzapine Tablets, the generic version of Eli Lilly’s Zyprexa.

Two patients died 3-4 days after receiving an intramuscular injection of Zyprexa Relprevv (olanzapine pamoate extended-release).

Symbyax (olanzapine and fluoxetine HCl, from Lilly) capsules have been FDA approved for the acute treatment of treatment-resistant depression (TRD).