U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Diso... (gain greater than or equal to 7 percent ...)

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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)

Date:11/20/2007

gain greater than or equal to 7 percent increase from baseline was seen in 5 percent of adult patients treated with adjunctive ABILIFY and 1 percent of adjunctive placebo-treated patients. The mean change from baseline in weight was 1.7 kilograms (kg) for adjunctive ABILIFY and 0.4 kg for adjunctive placebo.

In a pool of two placebo-controlled trials of patients, the rate of discontinuation due to adverse reactions with the use of adjunctive ABILIFY compared to placebo plus ADT was 6 percent vs 2 percent, respectively. The most commonly observed adverse reactions (incidence greater than or equal to 5 percent and at least twice the incidence of placebo plus ADT) associated with the use of adjunctive ABILIFY were akathisia (25 percent vs 4 percent), restlessness (12 percent vs 2 percent), insomnia (8 percent vs 2 percent), constipation (5 percent vs 2 percent), fatigue (8 percent vs 4 percent) and blurred vision (6 percent vs 1 percent).

About Major Depressive Disorder

Major depressive disorder is a serious mental illness(4)characterized by one or more major depressive episodes.(5) Depression affects approximately 13 to 14 million adults,(2) or about 6.7 percent of the adult population in a given year,(6) and is one of the most common mental health disorders.(7) Depression is one of the leading causes of disability in the U.S.(8) In 2000, the total economic burden of treating depression in the U.S. was $83.1 billion, with workplace costs, including missed days and lack of productivity due to illness, accounting for the majority of the total economic burden (62 percent).(9) Other economic burdens in 2000 included $26.1 billion (31 percent) for treatment costs and $5.4 billion (7 percent) for suicide- related costs.(9)

About ABILIFY

The first and only available dopamine partial agonist, ABILIFY is indicated as adjunctive treatment to antidepressant therapy in adults with major depressive disorder.

Initially approved in November 2002,
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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Diso...(gain greater than or equal to 7 percent ...)