FDA Approves New Extended-Release Injectable for Schizophrenia and Bipolar Disorder
Long-acting medications can help people better manage their treatment, leading to improved quality of life.
For some people with schizophrenia and bipolar 1, long-acting injectable drugs (LAI) can help provide a steady dose of medication, which can make a major difference in how well their condition is managed.
Abilify Asimtufii (aripiprazole), an extended-release injectable version of Abilify (aripiprazole) taken once every two months, was approved on April 27, 2023, by the U.S. Food and Drug Administration (FDA), according to a release from Otsuka and Lundbeck, the pharmaceutical companies behind the drug.
Aripiprazole has been available as a once-monthly injectable under the brand name Abilify Maintena since its FDA approval in 2013. The longer-lasting Abilify Asimtufii is approved for the same patient population, and is given via injection in the gluteal muscle by a healthcare professional.
Abilify Asimtufii Found to Be Effective in Treating Schizophrenia and Bipolar 1
The efficacy of Abilify Asimtufii is based on the earlier studies used for Abilify Maintena in the treatment of schizophrenia or maintenance treatment of bipolar 1 disorder in adults.
The bimonthly long-acting injectable formulation Abilify Asimtufii, in 960 and 720 milligram prefilled syringes, delivered sustained plasma concentrations comparable to that demonstrated in studies with the once-a-month version and was just as effective, according to the findings.
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The medicine was generally well-tolerated and safe, and there were no new safety issues compared with the one-month version. The most common adverse reactions reported were increased weight, akathisia (restlessness), injection site pain, and sedation. Important safety information can be found on the Abilify Maintena website.
Schizophrenia and Bipolar Disorder Are Often Untreated
It’s estimated that there are about 2.8 million people living in the U.S. with schizophrenia, according to The Treatment Advocacy Center. Schizophrenia is a mental disorder that can cause disruptions in thought processes and delusions that aren’t based in reality.
Even though schizophrenia is relatively rare, it’s one of the top 15 leading causes of disability worldwide. It’s estimated that the average life potential lost for people with the disorder is 28.5 years, according to the National Institute of Mental Health (NIMH). An estimated 2 in 5 people with schizophrenia are untreated in any given year, per the Treatment Advocacy Center.
Bipolar disorder can be divided into 3 classes: bipolar 1, bipolar 2, and cyclothymic disorder. There is also a fourth “unspecified” type, when a person experiences significant mood elevations but doesn’t meet enough criteria for the first three classes.
Bipolar disorder was formerly called manic depression, and the hallmark symptom is dramatic shifts in mood, energy, and activity levels that get in the way of carrying out day-to-day tasks and responsibilities, according to the NIMH.
It’s estimated that about 4.4 percent of U.S. adults experience bipolar disorder at some point in their lives. More than half of people with this condition are untreated in any given year.
The Benefits of Long-Acting Injectables to Treat Schizophrenia and Bipolar
These long-acting medications for schizophrenia and bipolar have been around for quite a while and they may help patients keep taking their antipsychotic medications, says Travis Krew, MD, a psychiatrist at Cleveland Clinic in Ohio, who was not involved in these trials or the companies that are manufacturing the drug.
“It can be challenging to take a tablet or pill each day, and it is even harder when taking multiple medications, perhaps several times per day. Setting alarms, using pill organizers, or creating other reminders may help some patients, but they don't work for everyone,” says Dr. Krew. Missed medication doses often result in worsening symptoms, which may make it harder for a patient to function, sometimes resulting in hospitalization, he adds.
The fact that these medications need to be administered by a medical professional is another positive, says Krew. “This often allows for more opportunities for a patient to check in with a healthcare provider about their symptoms,” he says.
For some people, the steady medication levels may help with side effects, he says. “Individuals who notice side effects when their oral medication level peaks in the bloodstream, usually within a couple of hours after taking their oral medication, may benefit from the more consistent blood level offered by long-acting injectable antipsychotics,” says Krew.
When Will Abilify Asimtufii Be Approved and How Much Will It Cost?
The drug is expected to be available early this summer, according to an Otsuka spokesperson. Right now, pricing information is not available, but the company expects Abilify Asimtufii will be covered by commercial insurance.