New Medication for Schizophrenia and Bipolar I

Angie Szumlinski
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June 28, 2021
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On June 1, 2021, Aklermes announced FDA approval of LYBALVI™ for the treatment of schizophrenia and Bipolar I disorder. The following was published as part of their press release announcement:

“Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly-efficacious atypical antipsychotic, is associated with significant side effects, including weight gain, that may impact patients’ treatment experiences and limit its use,” said René S. Kahn, M.D., Ph.D., Esther and Joseph Klingenstein Professor & Chair, Department of Psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai. “With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, LYBALVI brings a welcome new addition to our medication arsenal.”

LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.

LYBALVI is contraindicated in patients:

  • Using opioids
  • Undergoing acute opioid withdrawal

NOTE: LYBALVI is not approved for the treatment of patients with dementia-related psychosis. Mental health can be a difficult subject for many people, sadly is misunderstood and often times “under studied”. We need to remember, mental health disease is like any other disease and at the end of the day, people suffer. Treat your residents with mental health diagnoses with the same dignity and respect you would treat someone with a diagnosis of cancer, Parkinson’s, Alzheimer’s or a repaired hip fracture! That said, it is refreshing to see a pharmaceutical company doing research that may help some of the residents we care for. Stay informed, stay well and stay tuned!


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