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New Data on Brexpiprazole in Major Depressive Disorder

Serotonin–dopamine activity modulator completes phase III study (January 24)

New clinical trial data on the investigational compound brexpiprazole (Otsuka/Lundbeck) will be presented at the 22nd European Psychiatry Association (EPA) Congress in Munich, Germany, on March 2, 2014.

Findings from a completed phase III, randomized, placebo-controlled study investigating the effect of brexpiprazole as adjunctive therapy to antidepressant treatment in patients with major depressive disorder (MDD) will be discussed. Overall, brexpiprazole was effective and well tolerated as adjunctive treatment for MDD patients who had shown an inadequate response to antidepressant therapy.

Highlighted data will include:

  • Adjunctive brexpiprazole achieved statistically significant improvements in the mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score compared with placebo.
  • Brexpiprazole had a statistically significant advantage over placebo on all secondary endpoints.
  • The most common adverse events reported in patients receiving brexpiprazole included weight gain and akathisia.
  • More than 90% of the patients completed the randomized phase of the trial.

Brexpiprazole is a serotonin–dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and as an antagonist at 5-HT2A and noradrenaline alpha1B receptors.

The drug is in phase III clinical testing for adjunctive treatment of MDD and for schizophrenia. Additional phase III trials include patients with agitation associated with dementia of the Alzheimer’s type, and adult patients with post-traumatic stress disorder.

Source: Lundbeck; January 24, 2014.

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