FDA approves Lundbeck and Otsuka’s Rexulti for depression
pharmafile | July 14, 2015 | News story | Sales and Marketing | FDA, Lundbeck, Otsuka, Rexulti, US, brexpiprazole, depression, major depressive disorder, schizophrenia
Lundbeck and Otsuka have gained a yes vote from the FDA for their jointly-marketed antidepressant, Rexulti.
The US regulator approved the drug as an adjunctive therapy for the treatment of major depressive disorder (MDD) in adults with schizophrenia. As a result of the decision, the companies say Rexulti (brexpiprazole) is expected to become available in the US in early August 2015.
The mechanism of action of Rexulti in the treatment of MDD or schizophrenia is not known. However, Rexulti may work through a combination of its effects on serotonin and dopamine receptors.
Rexulti was studied in more than 4,300 subjects in Phase II and III clinical trials, and the approval was supported by four Phase III studies in the now-approved indications – two studies as adjunctive therapy to antidepressants in MDD and two studies in schizophrenia.
However the drug comes with several safety warnings, including an increased risk of death in elderly patients with dementia-related psychosis, and like some other antidepressants, an increased risk of suicidal thoughts and behaviour in people aged 24 years and younger.
“Psychiatric diseases remain a challenging therapeutic area where many people are unsatisfied with their treatments,” notes Tatsuo Higuchi, president of Otsuka Pharmaceuticals. “The approval of Rexulti is another example of Otsuka and Lundbeck’s commitment to bringing new therapeutic alternatives to the mental health community.”
“All treatment options require healthcare providers, patients and caregivers to balance efficacy and tolerability in managing their diseases,” says Kåre Schultz, president and chief executive at Lundbeck. “We are proud to introduce Rexulti to help adult patients living with MDD and schizophrenia.”
“For some patients with MDD, antidepressant monotherapy is not enough, and these patients continue to suffer from unresolved symptoms,” says Dr Michael Thase, a professor of psychiatry and director of the mood and anxiety program at the University of Pennsylvania school of medicine.
“In the clinical trials that led to the FDA’s approval, adding brexpiprazole to ongoing antidepressant therapy helped MDD patients improve unresolved symptoms of MDD.”
Lilian Anekwe
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