Adjunct brexpiprazole safe, well-tolerated for MDD

NEW YORK — Adjunctive treatment with brexpiprazole was generally well-tolerated for up to 52 weeks in adults with major depressive disorder, and long-term treatment was linked to continued improvement in efficacy and function, according to a data presented here.

“We need to know in the treatment of depression which treatments we can continue to give and whether it’s safe,” Nanco Hefting, of H. Lundbeck A/S, Denmark, told Healio Psychiatry. “Patients were initially recruited to an acute treatment study where we investigated the acute effects over 6 weeks of brexpiprazole vs. placebo. When patients completed these studies, they had the opportunity to roll-over into this long-term study.”

The investigators examined the long-term safety, tolerability and therapeutic effect of 0.5 mg to 3 mg/day brexpiprazole (Rexulti, Otsuka Pharmaceutical/Lundbeck) used alongside antidepressants in adults with major depressive disorder. To determine the frequency and severity of treatment-emergent adverse events, patients from three randomized, double-blind, placebo-controlled phase 3 studies were enrolled into this 52-week open-label study, which was amended to 26 weeks after a sufficient number of patients achieved long-term exposure. In total, 2,944 patients were enrolled, and 1,895 completed the study.

At endpoint, the average daily dose of adjunctive brexpiprazole was 1.51 mg per day. The investigators found that the incidence of discontinuation due to treatment-emergent adverse events was 8.6% among participants who took at least one dose of brexpiprazole.

Furthermore, patients’ symptoms and functioning continued to improve throughout the study period. According to the authors, the average change from baseline in the Clinical Global Impression – Severity of Illness (CGI-S) score was –0.61 at week 26, and the CGI–Improvement (CGI-I) score was 2.54. At week 52, the change in CGI-S was –1.05 at week 52, and the severity score was 2.1.

Most treatment-emergent adverse events were mild or moderate in severity, according to the investigators. Adverse events that occurred at a rate of 5% or greater included weight gain, somnolence, headache, akathisia, insomnia and increased appetite.

“The results of the study show that even prolonged treatment with brexpiprazole is a safe option for patients to continue,” Hefting told Healio Psychiatry. “Most patients can tolerate the drug quite well and the withdrawal rate in the study was low considering the length of treatment with 85% of patients able to have at least a half-year treatment. There was a high proportion of patients who completed 1-year treatment relative to comparable trials in this area.” – by Savannah Demko

Reference:

Hefting N, et al. Poster P6-069. Presented at: American Psychiatric Association Annual Meeting; May 5-9, 20178; New York.

Disclosures: Hefting is an employee of Lundbeck.