New Drug for Schizophrenia and Bipolar Disorder

The medication Lybalvi treats schizophrenia and bipolar disorder symptoms without the weight gain associated with other drugs used for these brain disorders.

Schizophrenia and bipolar disorder are two separate brain disorders. They can, however, share certain symptoms. That explains why people with schizophrenia and others with the most common type of bipolar disorder (bipolar I) are sometimes prescribed the same medications to control their conditions. Unfortunately, unwanted weight gain is associated with several of these prescription drugs — and extra pounds can not only be unpleasant but also unhealthy over time, often resulting in patients stopping their needed medications.

Good news: A drug approved by the Food and Drug Administration, olanzapine/samidorpha (Lybalvi), developed by biopharmaceutical company Alkermes, may be a solution for the weight gain problem associated with other drugs schizophrenia and bipolar patients need to feel and function better.

Research shows Lybalvi does not result in unexpected and unwanted weight gain. The treatment can be used, depending on the patient, as either a single medication for maintenance (monotherapy) or in combination with other medications.

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How the treatment can benefit schizophrenia and bipolar patients

Schizophrenia and bipolar disorder are separate conditions, often described as mental illnesses. The American Psychiatric Association refers to them as “chronic brain disorders” believed to be caused by a dysregulation of brain chemicals that control thinking and mood.

Schizophrenia is not common; it affects less than one percent of the U.S. population. If untreated or inadequately treated, schizophrenia can be a devastating health problem. When symptoms are active, people with the disorder often suffer from disorganized speech, trouble thinking, lack of motivation, delusions, and hallucinations. With treatment, however, most symptoms of the brain disorder improve significantly, and the odds of a recurrence are reduced, according to the American Psychiatric Association.

Bipolar disorder affects more people than schizophrenia, close to three percent of Americans. It causes dramatic shifts in energy, mood, and ability to think clearly, the National Alliance on Mental Illness explains. People with bipolar disorder experience periods of elation and energy (mania) and other periods of severe depression and extreme sadness. There are several types of bipolar disorder, which are diagnosed depending on the degree of symptoms and how often the occur.

The most serious type, defined by the National Institute of Mental Health, is bipolar I, marked by manic episodes lasting at least a week or that are so severe the person needs immediate and urgent hospitalization. Sometimes, a person with bipolar I who is experiencing severe episodes of mania or depression may have hallucinations or delusions, not unlike someone with untreated schizophrenia. So, the same medications are often used to treat both schizophrenia and bipolar I.

One of the most effective drugs for schizophrenia and bipolar I symptoms has long been the antipsychotic olanzapine (Zyprexa), made by Eli Lilly. The medication, however, is linked to significant weight gain in patients. Now, people needing treatment for schizophrenia or bipolar I disorder can be prescribed Lybalvi instead.

How the new drug works

Here’s how the new medication works to treat both schizophrenia and bipolar disorder: Lybalvi combines the active ingredient in Zyprexa with samidorphan, a new chemical entity designed to counter the weight-inducing effects of olanzapine. The medication is taken once a day in a pill.

Some patients may need additional medications, and there’s no “one size fits all” for schizophrenia or bipolar disorder. Side effects and individual reactions to different therapies can occur, and it’s important for patients to see their doctors regularly.

There is reason to be encouraged that patients may be more likely to stick to the treatment. Medication compliance is extremely important in curtailing schizophrenia and bipolar I symptoms and keeping them under control.

Several published studies evaluating the drug in people with schizophrenia, ranging in age from teen years to old age, have found Lybalvi to be safe and effective, and it reduced the risk of weight gain over several months.

"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 neuropsychiatrist René S. Kahn, MD PhD, professor and system chair of psychiatry 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."

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