Psych Congress

Psych Congress

September 19, 2017
2 min read

Novel drug associated with long-term remission in schizophrenia

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Ruth Duffy

NEW ORLEANS — Rexulti, a serotonin-dopamine activity modulator, may help individuals with schizophrenia achieve sustained long-term remission, according to data presented at Psych Congress.

“This post-hoc analysis was conducted to analyze the long-term remission of schizophrenia patients based on pooled data from patients in two short-term, placebo-controlled studies — Vector2 and Beacon3 — who continued into the open-label extension of these studies in Zenith4,” Ruth Duffy, PhD, medical director of Otsuka Pharmaceutical Development and Commercialization, told “The analysis showed that, in addition to showing efficacy and tolerability in treating acute exacerbation of schizophrenia, Rexulti patients receiving 2 mg and 4 mg per day showed sustained long-term remission over greater than 1 year.”

In two short-term studies, individuals with acute schizophrenia were randomly assigned to fixed once-daily doses of Rexulti (brexpiprazole, Otsuka Pharmaceutical/Lundbeck) 0.25 mg, 1 mg, 2 mg or 4 mg, or placebo for 6 weeks.

To determine long-term efficacy of brexpiprazole, researchers conducted an open-label, 52-week safety extension study among participants who received 2 mg or 4 mg of brexpiprazole in the short-term studies. Participants received 1 mg to 4 mg of brexpiprazole per day in the current analysis.

From baseline to week 6, participants who received 2-mg (P = .0004) or 4-mg (P < .0001) brexpiprazole exhibited superior mean changes in Positive and Negative Syndrome Scale total scores compared with placebo.

At week 26, researchers observed sustained remission in 26.7% of the 2-mg arm and 33.2% of the 4-mg arm.

By week 58, the rate of sustained remission was 32.1% in the 2-mg arm and 35.8% in the 4-mg arm.

Robert McQuade
Robert McQuade

Overall, 14.1% of participants withdrew due to worsening of schizophrenia; 1.2% withdrew due to psychotic disorder; and 0.9% withdrew due to agitation.

“For practicing health care providers, the open-label studies show that Rexulti may help nearly one-third of people living with major depressive disorder achieve sustained remission when used as an adjunct to antidepressant treatments and as a monotherapy; Rexulti may provide those living with schizophrenia an option to sustain long-term remission,” Robert McQuade, executive vice president and chief strategic officer of Otsuka Pharmaceutical Development and Commercialization, told – by Amanda Oldt


Baker RA, et al. Effect of brexpiprazole on long-term remission in adults with schizophrenia: Results of an open-label, long-term study. Presented at: U.S. Psychiatric and Mental Health Congress; Sept. 16-19, 2017; New Orleans.

Disclosure: The researchers are employees of Otsuka Pharmaceutical and Lundbeck.