Lybalvi: A New Treatment for Schizophrenia and Bipolar Disorder

By AJ Guimond, PharmD Candidate 2022
University of Arizona

May 10, 2022

Lybalvi

A new drug, Lybalvi (LIE-BAL-VEE) was recently made available in the United States in May of 2021. The Food and Drug Administration (FDA) has approved this drug for the treatment of schizophrenia and bipolar I disorder in adults.

Schizophrenia and Bipolar I Disorder

Chances are, you have heard of at least one of these mental health conditions before. These disorders affect millions of people every year. Unfortunately, they do not have a “cure” and can be complex to treat. However, effective drug treatments have come out that help control symptoms. Before looking at treatments, it is important to understand how these disorders work.

Doctors can usually diagnose a person with schizophrenia by their symptoms. The symptoms of schizophrenia may include delusions, hallucinations, and/or disorganized thoughts, speech, and behavior. The cause of schizophrenia is not fully known. However, previous studies have linked it to environmental factors and/or chemical imbalance of neurotransmitters in the brain.

Notably, it is often believed that this disorder may come from irregular or elevated levels of dopamine in the body, though the exact pathophysiology is not completely understood. The neurotransmitter dopamine is often called the “feel good” chemical because it is associated with the brain’s reward system. Inconsistent or elevated levels of dopamine may be a main cause of having schizophrenia. Besides dopamine, other brain chemicals like serotonin and glutamate may also play a role in the development of schizophrenia, but the exact associations have never been concretely established through research.

Bipolar I disorder is another common mental health disorder that doctors can diagnose by extreme mood swings. People with bipolar I disorder may have moments of extreme excitement or extreme depression and is often unpredictable. The cause is unknown, but many scientists believe genetics, mental or physical trauma, and environmental factors may play a role in the development of bipolar disorder.

These conditions have similar medical treatments. Both conditions may be treated with a class of drugs known as “antipsychotics.” This class of drugs consists of two groups: “Typical” or first-generation, and “Atypical” or second-generation antipsychotics.

What is Lybalvi?

Lybalvi is a combination drug that consists of two medications: olanzapine and samidorphan. Olanzapine (Brand name Zyprexa) is an “atypical” antipsychotic that doctors prescribe to millions of people every year. Samidorphan is a new medication to the market that is currently only found in Lybalvi. This drug is known as an “opioid receptor antagonist”: a class of medications typically used to deter abuse in people taking opioids.

How does Lybalvi differ from olanzapine by itself? What is the benefit?

The answer is that Lybalvi was designed to cause less weight gain than olanzapine by itself. This is where the new drug samidorphan comes into play. The opioid system in the body is believed to play a role in the regulation of body weight and food intake. Given that one of the key issues with olanzapine is weight gain, the new drug samidorphan in Lybalvi gives a new way to get the benefits of olanzapine without gaining as much weight. The amount of weight gain in people taking olanzapine by itself will vary among people (not everyone will gain weight), but some people may gain over ten percent of their body weight after starting olanzapine. This can be a severe problem for people who are obese, people with eating disorders, or anybody where weight gain would be a cause for concern. Lybalvi could offer a potential solution to this barrier of treatment.

Lybalvi may be a potential solution

If you have been diagnosed with schizophrenia or bipolar I disorder, Lybalvi may be a potential treatment for you. There are several factors to take into account before starting Lybalvi. Talk to your doctor at your next appointment about your treatment options and whether this drug would be right for you.

What you should know before starting Lybalvi

Lybalvi is not appropriate in everyone. Talk to your doctor and pharmacist about side effects, precautions to take, and potential drug interactions if you are starting Lybalvi. Common possible side effects include weight gain, dry mouth, headache, constipation, increased appetite, dizziness. When starting Lybalvi, you should report side effects to your doctor and pharmacist. In some cases, your doctor may lower your dose or take you off Lybalvi if side effects are intolerable.

Lybalvi should not be prescribed for people taking opioids, such as morphine or oxycodone. The new drug, samidorphan, attaches to opioid receptors in the brain and can “kick off” opioids that are already attached to these receptors. If there are still opioids present in the body, this may trigger an opioid withdrawal. If you are on chronic opioid therapy, olanzapine alone or another drug altogether may be more appropriate.

Some drugs besides opioids are not appropriate to take together with Lybalvi. You should talk to your doctor or pharmacist about potential drug interactions with Lybalvi and your other medications.

Resources:

FDA Package Insert and Prescribing Information

Lybalvi.com

A meta-analysis comparing short-term weight and cardiometabolic changes between olanzapine/samidorphan and olanzapine

Dopamine in schizophrenia: a review and reconceptualization

Bipolar Disorder - NIH

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