Forest Laboratories, Inc. (NYSE:FRX) announced today that FETZIMA™ (levomilnacipran ER capsules), is now available in pharmacies throughout the United States. FETZIMA was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder (MDD), also known as depression, in adults in July 2013.
“We are pleased to announce that FETZIMA is now available to patients,” said Dr. Marco Taglietti, Executive Vice President, Drug Development & Research and Chief Medical Officer. “Despite the number of available antidepressant medications, the treatment of depression remains a clinical challenge with a need for additional treatment options. In clinical studies, patients who received FETZIMA vs. placebo experienced meaningful improvement in their depressive symptoms and functional impairment. The availability of FETZIMA is a significant step forward in our goal of bringing a range of treatment options to adults living with MDD.”
FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI). The efficacy of FETZIMA was established in three positive double-blind Phase III studies comprising two fixed-dose studies and one flexible-dose study that compared FETZIMA to placebo in adults with MDD. A total of more than 1,600 adult patients received a once-daily dose of either FETZIMA (40, 80, 120 mg) or placebo in the three studies. In all three studies, significant improvement in depressive symptoms was demonstrated across 3 FETZIMA dosage strengths (40, 80, and 120 mg) once daily, as measured by the change from baseline to Week 8 in the MADRS total score. MADRS is a widely used, physician-rated scale for assessing the severity of depressive symptoms. Each of the 10 symptoms is rated on a scale of 0-6; higher numbers denote greater severity of symptoms.
For study 1, the mean baseline MADRS total score was 36 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at all three FETZIMA doses (-3.2 at 40 mg/day, -4.0 at 80 mg/day, and -4.9 at 120 mg/day). For study 2, the mean baseline MADRS total score was 31 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at both FETZIMA doses studied (-3.3 at 40 mg/day, -3.1 at 80 mg/day). For study 3, the mean baseline MADRS total score was 35 for both treatment groups. The LS mean difference from placebo in change from baseline was statistically significant for the FETZIMA dosing range studied (-3.1 at 40-120 mg/day).