FDA approved levomilnacipran extended-release capsules (Fetzima) for the treatment of major depressive disorder (MDD) in adults, according to the manufacturers, Forest Laboratories and Pierre Fabre Laboratories.
The serotonin and norepinephrine reuptake inhibitor (SNRI) will be available to wholesalers in the fourth quarter of this year.
The SNRI was approved following three placebo-controlled, double-blind phase 3 trials of two fixed-dose studies and one flexible-dose study. More than 1,600 adults received a one-daily dose of levomilnacipran (40, 80, 120 mg) or placebo in the trials. The primary end point in each study was change from baseline to end point in the Montgomery Asberg Depression Rating Scale (MADRS) total score, and the secondary end point was change from baseline to end point in the Sheehan Disability Scale (SDS) total score, according to a press statement.
In all three studies, levomilnacipran showed statistically significant improvement compared with placebo in both the primary and secondary end points. In study 1, the mean baseline MADRS total score was 36 in the treatment groups. At week 8, the mean difference from placebo in baseline change was -3.2 at 40 mg/day, -4.0 at 80 mg/day, and -4.9 at 120 mg/day—which was statistically significant for levomilnacipran-treated patients. In study 2, the mean MADRS total score was 31 for the treatment groups. The mean difference from placebo in baseline change was statistically significant with -3.3 at 40 mg/day and -3.1 at 80 mg/day. In study 3, the mean baseline MADRS total score was 35 for all treatment groups. The mean difference from placebo in baseline change was -3.1 at 40-120 mg/day in the treatment groups.
“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, CEO, and president of Forest Laboratories. “The approval of Fetzima fulfills that commitment to the millions of people living with MDD.”
The most common side effects in the placebo-controlled trials were nausea, constipation, hyperhidrosis, increased heart rate, erectile dysfunction, tachycardia, vomiting, and palpitations. The only dose-related side effects that were greater than 2% in overall incidence were urinary hesitation and erectile dysfunction.