Monday, July 29, 2013

FDA Approves Medication for Major Depressive Disorder

Forest Laboratories Inc. and Pierre Fabre Laboratories announced July 26 that the FDA has approved their once-daily serotonin and norepinephrine reuptake inhibitor (SNRI) Fetzima (levomilnacipran extended release capsules) for treatment of major depressive disorder in adults.

The double-blind phase 3 studies used a daily dose of either Fetzima, ranging from 40mg to 120mg, or placebo for 8 weeks. Subjects were diagnosed with moderate to severe depression indicated by an average score of 34 on the Montgomery–├ůsberg Depression Rating Scale (MADRS) at baseline. The results showed a significant improvement in MADRS scores in Fetzima patients, with a 3.1 point difference between drug and placebo. A 2-point difference between drug effect and placebo general indicates a meaningful improvement in depressive symptoms.

“I’m in favor of having more drugs available for patients,” said Alan Schatzberg, M.D., a professor in the Department of Psychiatry and Behavioral Sciences at Stanford University and a past APA President. “One drug does not have the same efficacy in every patient,” he told Psychiatric News. Schatzberg mentioned that more studies should be conducted to compare Fetzima with other available SNRIs.

Read more about treatment for depressive disorders in Psychiatric News here and in the American Psychiatric Publishing Textbook of Mood Disorders here. Schatzberg is a coeditor of that volume.

(Image:Robert Red/