FDA Approves Fourth SNRI to Treat Depression

Levomilnacipran (Fetzima) is now FDA approved as a once-daily serotonin and norepinephrine repuptake inhibitor (SNRI) to treat major depression disorder (MDD) in adults. Levomilnacipran, developed by Pierre Fabre Laboratories and Forest Laboratories, is now the fourth such drug approved in the United States.

According to the manufacturer, Fetzima is a once-daily sustained release formulation. Clinical trials found statistically meaningful improvement in depressive systems and functional impairment with 40, 80, and 120 mg doses vs. placebo, as measured by the Montgomery Asberg Depression Rating Scale and the Sheehan Disability Scale.

“As many people with MDD struggle to find a treatment that works for them, FETZIMA provides patients and physicians with an additional option for treating this serious disease,” said Michael Liebowitz, MD, Professor of Clinical Psychiatry at Columbia University.

Side effects were reported in less than 5% of the study group and included nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations.          

Fetzima is expected to be available in the 4^th quarter of 2013.

For more information, visit www.pierre-fabre.com.