By Saabira Chaudhuri
Forest Laboratories Inc. (FRX) and Pierre Fabre Laboratories on Friday said their treatment for depression was approved by the U.S. Food and Drug Administration.
Fetzima is a once-daily serotonin and norepinephrine reuptake inhibitor discovered by Pierre Fabre Laboratories and co-developed by Forest Labs.
According to the companies, depression--or Major Depressive Disorder--affects almost 16 million adults in the U.S. every year.
In late-stage studies of adult patients with MDD, statistically significant and clinically meaningful improvement in depressive symptoms was demonstrated across three Fetzima dosage strengths of 40, 80, and 120 mg once daily compared with placebo.
Forest Labs said it expects Fetzima to be available to wholesalers in the fourth quarter.
Like other pharmaceutical companies that have lost market exclusivity on major drugs, Forest Labs has been striving to shore up its sales with new drugs as it also aims to build up its pipeline--partly through collaborations and licensing deals. The company's former main revenue source, the antidepressant Lexapro, lost patent exclusivity last year.
Earlier this week, Forest reported its fiscal first-quarter earnings fell 58% as a sharp drop in Lexapro sales continued to hamper the drug maker's bottom line, although revenue improved.
Shares closed Thursday at $43.99 and were inactive premarket. The stock has risen 19% in the past three months.
Write to Saabira Chaudhuri at saabira.chaudhuri@wsj.com
