This past week, the U.S. Food and Drug Administration (FDA) approved Rexulti (brexpiprazole) as an adjunct therapy for the treatment of adults with major depressive disorder (MDD, also known as clinical depression) and for adults with schizophrenia. It is expected to be available to patients in August.
Research demonstrating Rexulti’s clinical effectiveness was conducted on more than 4,300 patients, with four placebo-controlled studies (two each for depression and schizophrenia).
“Schizophrenia and major depressive disorder can be disabling and can greatly disrupt day-to-day activities,” noted Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research. “Medications affect everyone differently, so it is important to have a variety of treatment options available for patients with mental illness.”
For clinical depression, Rexulti was studied in two separate 6-week, placebo-controlled clinical trials of adults diagnosed with major depressive disorder. Patients enrolled in these studies previously failed to reach an adequate response during previous antidepressant drug treatments. The studies found a significant difference between those taking Rexulti and those taking placebo on the Montgomery-Asberg Depression Rating Scale (MADRS), a measure of depressive symptoms.
Akathisia — agitation or restlessness — and weight increase were the most common and significant side effects in people taking Rexulti for depression.
For schizophrenia, two separate studies were conducted. These were also 6-week, placebo-controlled clinical trials of adults diagnosed with schizophrenia. On a standard measure of schizophrenia symptoms called the Positive and Negative Syndrome Scale (PANSS), Rexulti proved to be superior than placebo.
“One key priority for physicians is to find medications that help improve symptoms and are tolerable for patients,” said Dr. Christoph Correll, Professor of Psychiatry, Hofstra North Shore LIJ School of Medicine and lead author of one of the studies.
“In the Rexulti clinical trials for schizophrenia, we saw a combination of efficacy and symptom improvement within a tight target dose range with one adverse event — weight increase — occurring in at least 4 percent of patients and with twice the incidence of placebo.”
Once available in August 2015, brexpiprazole will be prescribed in a once-daily oral dose that can be taken with or without food. The drug is manufactured by Otsuka Pharmaceuticals.
Rexulti will carry a boxed warning alerting health care professionals about an increased risk of death with off-label use for treating behavioral problems in older persons with dementia-related psychosis, as well as an increased risk of suicidal thinking and behavior in children, teens, and young adults. This boxed warning is common to many antidepressant drugs.
For depression, the company recommends clinicians initiate treatment at 0.5 mg or 1 mg once daily. Titrate at weekly intervals to 1 mg once daily, then up to the target dosage of 2 mg once daily based on the patient’s clinical response and tolerability.
For schizophrenia, the company recommends clinicians initiate treatment at 1 mg once daily for the first 4 days. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on the patient’s clinical response and tolerability.