NEW ORLEANS — Poster data presented here at Psych Congress indicated three dosages of Rexulti improved depression remission rates among individuals with inadequate response to antidepressants.
“This post-hoc analysis was conducted to analyze the long-term efficacy of Rexulti used as adjunctive treatment in patients with major depressive disorder [MDD], who had an inadequate response to antidepressants,” Keva Gwin, PharmD, director of medical affairs at Lundbeck, told Healio.com/Psychiatry. “The analysis was based on the data from two U.S. pivotal studies and an open-label extension study. The analysis found that nearly one-third of patients with MDD who had an inadequate response to one to three antidepressant treatments achieved sustained remission after treatment with Rexulti, adjunctive to antidepressants, at doses of 2 mg and 3 mg per day.”
To determine short-term efficacy of Rexulti (brexpiprazole, Otsuka Pharmaceutical/Lundbeck), researchers conducted two randomized, double-blind, placebo-controlled, fixed-dose phase 3 studies among adults with MDD with poor response to their current antidepressant. Studies included a screening phase from 7 to 28 days, an 8-week single-blind prospective phase, and a 6-week double-blind randomized treatment phase.
At the end of the prospective phase, participants with remaining depression after receiving one to three prior antidepressants were randomly assigned to receive 1 mg, 2 mg or 3 mg of brexpiprazole plus antidepressant or placebo plus antidepressant.
To assess long-term efficacy, researchers conducted an open-label, 52-week safety study that was amended to 26 weeks due to “sufficient exposure,” according to researchers. The cohort included participants who completed the short-term studies. Participants received a flexible dose (0.5 mg-3 mg) of adjunctive brexpiprazole.
At week 26, 29.4% of participants who received 1 mg of brexpiprazole, 36.7% of those who received 2 mg of brexpiprazole and 31.9% of those who received 3 mg of brexpiprazole had sustained remission.
Up to week 58, 38.1% of participants who received 1 mg of brexpiprazole, 43.6% of those who received 2 mg of brexpiprazole and 38% of those who received 3 mg of brexpiprazole had sustained remission.
“The results show that nearly one-third of a difficult-to-treat population of patients with MDD can achieve sustained remission after treatment with brexpiprazole adjunctive to [antidepressants],” the researchers wrote in the poster. “Long-term adjunctive treatment with brexpiprazole (0.5 to 3 mg daily) was safe and well-tolerated in patients with MDD who had inadequate response to [antidepressants].” – by Amanda Oldt
Weiss C, et al. Long-term efficacy of adjunctive brexpiprazole in major depressive disorder: Pooled analysis of two short-term placebo-controlled studies and of an open-label, long-term extension study. Presented at: U.S. Psychiatric and Mental Health Congress; Sept. 16-19, 2017; New Orleans.
Disclosure: The researchers are employees of Otsuka Pharmaceutical or Lundbeck.
Editor's note: Remission rates for week 58 were corrected on Sept. 20.