Study data showed that Rexulti plus antidepressant therapy (ADT) at 2mg and 3mg was superior to placebo.
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Rexulti (brexpiprazole) has been approved by the U.S. Food and Drug Administration to treat schizophrenia, and as an add-on drug for major depressive disorder (MDD) when a first-line drug fails to effectively treat symptoms. The incidence of somnolence (also including sedation and hypersomnia) in all patients with schizophrenia who received brexpiprazole (n = 1,256) was 5% compared with 3% for patients receiving placebo (n = 463).
The effectiveness of Rexulti as an add-on treatment for MDD was evaluated in two 6-week trials that compared Rexulti plus an antidepressant to placebo plus an antidepressant in 1,046 participants for whom an antidepressant alone did not adequately treat their symptoms.
The medicine, brexpiprazole, was admitted since an adjunctive therapy treatment for huge a depressive disorder (Medical device directive), a bad mental ailment which can lead to prolonged feeling disappointment, aggrivation or ferocity, health and fitness valve said on Friday. The research team deemed 2 mg or 3 mg of Rexulti superior to placebo in reducing MDD symptoms, though the 1-mg dose was not found to be superior. For this treatment, researchers conducted two six-week clinical trials.
The efficacy of brexpiprazole in adults with schizophrenia was established in two 6-week, phase III, randomized, placebo-controlled studies that compared fixed doses of brexpiprazole with placebo.
Weight gain and a sense of restlessness were the most common side effects reported by patients taking Rexulti. The boxed warning also cautions that off-label use of brexpiprazole to treat behavioral problems among older individuals with dementia-related psychosis is associated with an increased risk for death.
The approval comes at a good time for Otsuka, a unit of Otsuka Holdings Co Ltd. The company’s US patent for a similar anti-psychotic, Abilify, which is sold by Bristol-Myers Squibb Co in the United States, expired in April.
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Finally, the FDA says, “Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors”.
