Forest Labs Posts Positive Results for Anxiety Disorder Drug

By Maria Armental

Forest Laboratories Inc. (FRX) reported positive top-line results from three Phase 3 trials of vilazodone in adult patients with generalized anxiety disorder.

In two flexible-dose and one fixed-dose eight-week trials, patients who received vilazodone showed statistically significant improvement, the New York specialty pharmaceutical company said.

Based on the results, the company said it will file a supplemental new drug application next year with the U.S. Food and Drug Administration.

Generalized anxiety disorders affect about 6.8 million American adults, causing them to be filled with fearfulness and uncertainty, according to the National Institute of Mental Health. It affects twice as many women as men, and the average age of onset is 31 years old.

Forest, which has been diversifying its product base in recent years, acquired the drug as part of its deal for Clinical Data Inc. in 2011, betting the then-newly approved vilazodone would help offset the loss of major products against looming generic competition.

Forest Labs is being bought by Dublin-based Actavis PLC for about $25 billion in a deal expected to close midyear.

Write to Maria Armental at [e-mail]

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