Men and women who take risperidone to treat schizophrenia or bipolar I have a new option if they aren’t able to take oral medications every day or prefer a long-lasting alternative. The U.S. Food and Drug Administration (FDA) approved Rykindo as an extended-release injectable version of risperidone on January 15, 2023, according to a press release from Luye Pharma, the company that developed the drug.

Rykindo is administered via intramuscular injection once every two weeks, delivering risperidone via long-acting and extended-release “microsphere” technology. These microspheres release medication at a gradual, steady rate. The injection needs to be administered by a healthcare professional.

Risperidone Has Long Been Used to Treat Schizophrenia and Bipolar I

Risperidone was first approved by the FDA in 1993 to treat symptoms of schizophrenia, according to StatPearls. A long-acting injectable form of risperidone was first approved by the FDA in 2003 and sold under the brand name Consta.

Risperidone was later approved in 2004 to treat symptoms of bipolar disorder.

Rykindo Begins Working With Relative Speed

When people get their first injection of risperidone — whether Rykindo or Consta — the drug doesn’t kick in right away. Patients need to continue to take the oral form, even after the injection, for a certain period of time; this is called the “oral overlap.”

For people who start on Rykindo, that period is seven days; for people taking Consta, that period is three weeks.

In general, the shorter the overlap, the better, because it means a patient will be guaranteed a consistent dosage sooner, says Travis Krew, MD, a psychiatrist at Cleveland Clinic in Ohio.

Long-Acting Injectables Can Be a Boon for People With Schizophrenia and Bipolar Conditions

Long-acting medications for schizophrenia and bipolar disorder have been around for a while; there are a number of typical and atypical antipsychotics available in this form, says Dr. Krew.

These medications are administered as injections every few weeks or months, rather than as daily pills. “This is particularly useful when we are looking to improve a patient’s adherence. It can be challenging to take medications every day, and many folks are on more than one medication,” says Krew.

Finding ways to ensure people get their medications regularly is especially important in schizophrenia, he says. “There’s a lot of great recent evidence that suggests that starting people early on these medications when their condition is first diagnosed can help with outcomes,” Krew says.

People with schizophrenia are most vulnerable in the early stage of the illness, and consistent medication for the first few months can really help them do better in their day-to-day life, says Krew.

In addition to medications, treatment for schizophrenia typically includes other forms of therapy, such as cognitive behavioral therapy and psychosocial rehabilitation, per American Psychiatric Association guidelines.

How Well Does Rykindo Work and What Are the Side Effects?

According to the results of clinical studies, in 5 percent or more of trial participants with schizophrenia, the most common adverse events were headache, parkinsonism (a general term referring to brain conditions that cause slowed movements, tremors, and stiffness), dizziness, akathisia (inability to remain still), fatigue, constipation, dyspepsia (indigestion or upset stomach), sedation, weight increase, pain in the extremities, and dry mouth.

A full list of potential risks and side effects of risperidone injection can be found at MedlinePlus.

In people with bipolar disorder, the most common adverse effects were weight increase (5 percent of participants) and tremor and parkinsonism (10 percent or more).

The drug carries a boxed warning regarding elderly patients with dementia-related psychosis. There is an increased risk of death for this population if they are treated with antipsychotic drugs. Rykindo is not approved for use in patients with dementia-related psychosis.

When Will Rykindo Be Available?

The FDA approval means that Rykindo can now be marketed and sold in the United States, but Luye Pharma has not yet specified an official release date or shared information on cost.

Schizophrenia and Bipolar Disorder Are Often Untreated

Schizophrenia is a mental disorder that can cause disruptions in thought processes and delusions that aren’t based in reality. According to the Treatment Advocacy Center (AOT), about 2.8 million adults living in the United States have schizophrenia, or about 1.1 percent of the population.

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. An estimated two in five people with schizophrenia are untreated in any given year, per the AOT.

Bipolar disorder can be divided into three classes: bipolar I, bipolar II, and cyclothymic disorder. Also called manic-depressive disorder, the hallmark symptom is dramatic shifts in mood, energy, and activity levels that get in the way of day-to-day tasks and responsibilities, according to the institute.

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.