FDAnews Drug Daily Bulletin

Otsuka, H. Lundbeck Report Positive Phase III Results for Depression Treatment

Jan. 28, 2014

Otsuka and H. Lundbeck say their brexpiprazole serotonin-dopamine activity modulator was effective as an adjunct to antidepressant therapy in 18- to 65-year-old patients with major depressive disorder with an inadequate response to antidepressants alone.

Results from the Phase III Pyxis trial — a multicenter, randomized, placebo-controlled study in the U.S., Europe and Canada — showed statistically significant improvements in average Montgomery-Åsberg Depression Rating Scale totals in patients treated with brexpiprazole compared with placebo. The drug also demonstrated a statistically significant advantage for all secondary outcome measures of change in the Sheehan Disability Scale to week 14 of treatment.

The drugmakers are conducting an extensive development program for brexpiprazole and expect to complete three more trials on depression and schizophrenia in the first half of this year. These studies will determine the feasibility of filing for regulatory approval in the U.S., Otsuka said.

Phase III tests are also underway to evaluate the drug in patients with agitation stemming from dementia stemming from Alzheimer’s disease dementia and in adults with posttraumatic stress disorder. — Lena Freund

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