FDA OKs Abilify for Depression

Antipsychotic Drug Approved for Use in Addition to Antidepressants for Treating Depression

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Nov. 20, 2007 -- The FDA has approved the antipsychotic drug Abilify for treatment of depression when used along with antidepressants.

Abilify isn't a new drug; it was first approved five years ago.

But it's the first drug approved by the FDA as an addition to antidepressants for adults with major depressive disorder, according to Otsuka Pharmaceutical Co. and Bristol-Myers Squibb.

Abilify was discovered by Otsuka Pharmaceutical Company, which partners with Bristol-Myers Squibb to sell Abilify in the U.S. and Europe.

In a news release, the drug companies report that the FDA's latest approval for Abilify was based on two studies that each lasted for six weeks.

Together, the studies included 743 depressed adults whose depression hadn't lifted despite the fact that they were taking antidepressants.

All of the patients kept taking antidepressants during the study. They also took Abilify or a placebo pill, without knowing which was which.

Before-and-after surveys show that the patients taking Abilify got more depression relief than those taking the placebo.

In those studies, Abilify's most common side effects were fidgeting, restlessness, insomnia, constipation, fatigue, and blurred vision.

Earlier this month, the FDA approved Abilify to treat schizophrenia in teens aged 13-17. But Abilify isn't approved to treat depression in children.

WebMD Health News Reviewed by Louise Chang, MD on November 20, 2007

Sources

SOURCES: FDA: "Label and Approval History: Abilify." News release, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co. WebMD Medical News: "FDA OKs Abilify for Teen Schizophrenia."

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