AT THE EUROPEAN CONGRESS OF PSYCHIATRY

MADRID (FRONTLINE MEDICAL NEWS) – Brexpiprazole, a new drug for treatment of schizophrenia that received Food and Drug Administration marketing approval in July 2015, showed good efficacy for patients with acute schizophrenia as well as a good safety profile in a combined analysis from three phase III trials that compared the drug against placebo.

“The incidence of withdrawals due to adverse effects was lower with brexpiprazole administered as 2-4 mg/day than with placebo, and the incidence of activating and sedating effects with brexpiprazole was low, Catherine Weiss, Ph.D. , reported at the meeting, sponsored by the European Psychiatric Association.

“For long-term treatment, the lower level of sedation from treatment with brexpiprazole is an advantage,” said Dr. Weiss, director of global medical affairs for Otsuka, the company that is marketing brexpiprazole (Rexulti) along with a partner company, Lundbeck.

“We hope that brexpiprazole will be suitable for outpatients with schizophrenia who still have the potential to function in the community, to work and have relationships. Our data show that brexpiprazole prevents schizophrenia relapses and is very well tolerated,” said Dr. Emmanuelle Weiller , a senior medical adviser with Lundbeck in Copenhagen.

In its announcement of the marketing approval for brexpiprazole last year, the FDA did not include any description of how the drug works. But according to a statement from Lundbeck, the efficacy of brexpiprazole may be mediated by partial or full agonist activity at certain serotonin or dopamine receptors. The drug also has high affinity for certain noradrenaline alpha receptors.

The FDA based its approval for treatment of adults with schizophrenia (the drug was simultaneously also approved for adjunctive treatment of adults with major depressive disorder) on the results from two pivotal trials that both were published last year ( Am Psychiatry. 2015 Sept 1;172[9]:870-80 and Schizophr Res. 2015 May;164[1-3]:127-35 ).

Dr. Weiss’ combined analysis used data collected in both of these trials as well as in a third trial, the results of which were reported in a separate talk during the same meeting session. The third brexpiprazole trial randomized 468 adults with schizophrenia to one of three treatment groups: patients who received a flexible brexpiprazole dosage, patients who received placebo, and patients randomized to treatment with quetiapine XR, a subgroup that served as an active reference arm but not a comparator arm.

The combined analysis focused on the 868 patients in any of the three trials who received either 2 mg or 4 mg of brexpiprazole daily and its comparison to 517 patients who received placebo during 6 weeks of treatment. The combined results showed an overall, average incremental reduction in the positive and negative syndrome scale (PANSS) score of 5.8 with brexpiprazole treatment compared with placebo, a statistically significant difference, Dr. Weiss reported . Treatment with brexpiprazole for 6 weeks also produced significant improvements compared with placebo for three secondary efficacy measures: clinical global impression of severity, clinical global impression of improvement, and personal and social performance.

The safety analysis showed that treatment-emergent adverse events leading to withdrawal from treatment occurred in 8% of patients on brexpiprazole and in 13% of those on placebo. None of the most common treatment-emergent adverse effects were substantially more common in the brexpiprazole-treated patients, compared with those on placebo.

Brexpiprazole’s likely role right now is as an alternative maintenance drug for patients whose schizophrenia is either not adequately controlled by an older agent, or for patients who experience intolerable adverse effects on an older drug and would like an alternative drug that does not interfere as much with their usual activities, Dr. Weiller said in an interview.

Dr. Weiss is an employee of Otsuka. Dr. Weiller is an employee of Lundbeck. Otsuka and Lundbeck funded these drug studies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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