Last week, the U.S. Food and Drug Administration (FDA) approved Perseris (risperidone), an injectable version of risperidone, for extended treatment of adult schizophrenia. After the drug is injected just under the skin in a person’s abdomen, the treatment appears to be effective for 30 days in adults. Risperidone is an atypical antipsychotic often prescribed for the treatment of schizophrenia.

Schizophrenia is a potentially debilitating mental illness in the people it strikes, resulting in hallucinations and delusions that make everyday activities and life challenging. Most people with schizophrenia benefit from nearly life-long treatment, with a focus on medications that help keep the worst symptoms of schizophrenia at bay.

However, remembering to take medication daily, or believing it is necessary to take in order to maintain a person’s freedom from the negative symptoms associated with schizophrenia can be a challenge. Once-monthly treatments can help alleviate this burden from people with schizophrenia.

Perseris’ main ingredient is risperidone, but uses an extended-release delivery system to allow it be implanted via an injection just under the skin (subcutaneous) in a patient’s abdomen that provides sustained levels of the drug over the course of an entire month.

The FDA approval was based on Perseris passing both safety and efficacy studies. Efficacy was assessed in a Phase 3 randomized, double-blind, placebo-controlled study of 354 adults with schizophrenia evaluated by two clinical scales: PANSS and CGI-S. Safety was assessed with 322 patients who were treated with the new medication for at least 6 months (234 of them were treated for a year or longer). The profile of Perseris was consistent with oral risperidone’s safety profile, according to its manufacturer, Indivior.

Increased weight, sedation, feeling sleepy, and musculoskeletal pain are the most common side effects. Patients should talk to their doctor if they experience any side effects, including injection site pain that does not go away after a few days. Perseris has the potential to impair judgment, thinking, and motor skills, so people taking the medication should refrain from operating hazardous machinery until they’re certain they have no such adverse effects from the medication.

Also according to the manufacturer, elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death. Perseris is not approved for use in patients with dementia related psychosis.

No supplemental risperidone nor pre-treatment dose appears necessary (and is not recommended) for this new treatment to achieve the same efficacy as oral risperidone. Perseris comes in either a 90 mg or a 120 mg dose and must be administered by a healthcare professional once monthly. Tell your doctor if you are pregnant or thinking about becoming pregnant while on Perseris.

“Schizophrenia is a devastating, chronic and often disabling mental health condition that impacts the lives of people suffering from this illness, their families and caregivers. The approval of Perseris brings us the opportunity to provide adult patients and their healthcare providers with an innovative treatment option that we believe will make a meaningful difference,” said Shaun Thaxter, Chief Executive Officer of Indivior in the news release associated with the FDA approval.

“People with schizophrenia face a complex patient journey that can be hindered by ignorance, apathy and stigma.”

“The studies carried out by Indivior suggest that Perseris may offer patients, caregivers and physicians a new once-monthly subcutaneous medication option to treat adults with schizophrenia,” said Maurizio Fava, Executive Vice Chair of the Massachusetts General Hospital (MGH) Department of Psychiatry and Indivior clinical research consultant.

People who wonder if they may be at risk for schizophrenia or schizophrenia-like symptoms should take Psych Central’s schizophrenia test, a free screening assessment that takes under 2 minutes to evaluate schizophrenia symptoms.

Source: FDA