Forest Laboratories, Pierre Fabre Laboratories announce that FETZIMA gets FDA approval for MDD

Forest Laboratories, Inc. (NYSE: FRX) 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 U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder (MDD) in adults.

“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”

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.

Data Highlights

The efficacy of FETZIMA was demonstrated 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, 120mg) or placebo in the three studies. In each study, the primary endpoint was change from baseline to endpoint in the Montgomery Åsberg Depression Rating Scale (MADRS) total score and the secondary endpoint was change from baseline to endpoint in the Sheehan Disability Scale (SDS) total score. In all three studies, statistically significant improvement was seen for the FETZIMA group compared with placebo on both the primary and secondary endpoints using both the mixed-effects model for repeated measures (MMRM) and last-observation-carried-forward (LOCF) analyses.

Primary Endpoint MADRS (Reduction in depressive symptoms)

In all three studies, FETZIMA demonstrated superiority over placebo in the improvement of depressive symptoms as measured by the change from baseline to Week 8 in the MADRS total score. MADRS is a widely used, clinician-rated scale to assess the severity of 10 depressive symptoms. A total MADRS score of 35 or greater is suggestive of severe depression. The primary efficacy endpoint in the pivotal trials was change from baseline to week 8 in the total MADRS score. A 2-point difference between drug effect and placebo is generally considered to represent a clinically meaningful improvement in depressive 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 all 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).

Secondary Endpoint SDS (Improvement in functional impairment)

FETZIMA also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score. SDS is a validated scale that measures the extent that emotional symptoms disrupt patient functioning in 3 life domains: work/school, social life, and family life with each item scored from 0 (unimpaired) to 10 (highly impaired).