Novel drug associated with long-term remission in schizophrenia

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 Healio.com/Psychiatry. “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

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 Healio.com/Psychiatry. – by Amanda Oldt

Reference:

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.