New SNRI Approved by FDA: Levomilnacipran

July 26, 2013 04:15 PM Eastern Daylight Time
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 in adults.

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).

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.

Source: Businesswire