Forest Laboratories, Inc. and Pierre Fabre Laboratories announced today that FETZIMA™ (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), discovered by Pierre Fabre Laboratories and co-developed by Forest Laboratories, Inc. was approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults.
Major depressive disorder, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms interfere with a person’s ability to work, sleep, study, eat, and enjoy once pleasurable activities.
MDD affects almost 16 million adults in the United States every year, with a range of severity from mild to severe.
In the placebo-controlled, pivotal Phase III studies of adult patients with MDD, statistically significant and clinically meaningful improvement in depressive symptoms (primary endpoint) was demonstrated across three FETZIMA dosage strengths of 40, 80, and 120 mg once daily compared with placebo as measured by the Montgomery Åsberg Depression Rating Scale (MADRS) total score (primary endpoint).
FETZIMA also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score (secondary endpoint).
“Because people respond differently to different medications, Forest Laboratories is dedicated to bringing a range of treatment possibilities to adults living with MDD, as part of our growing mental health portfolio,” said Howard Solomon, Chairman, Chief Executive Officer and President of Forest Laboratories. “The approval of FETZIMA fulfills that commitment to the millions of people living with MDD.”
"We are proud that another product stemming from Pierre Fabre’s research has received approval in the United States. This marketing authorisation represents a key milestone for our laboratory, and it confirms our choice to make neuropsychiatry a strategic axis of our R&D efforts, next to oncology and dermatology ", said Frédéric Duchesne, President Pharmaceutical Division, Pierre Fabre Laboratories.
The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in the placebo controlled trials were nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations.
Rates of adverse events were generally consistent across doses (40-120 mg); the only dose-related adverse events (greater than 2% overall incidence) were urinary hesitation and erectile dysfunction.
“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.
Forest Laboratories Inc. expects FETZIMA to be available to wholesalers in the 4th calendar quarter 2013.