Forest Laboratories, Inc. has introduced Fetzima(levomilnacipran ER capsules), in pharmacies throughout the United States. Fetzimawas approved by the US 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 Fetzimais 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 Fetzimavs. placebo experienced meaningful improvement in their depressive symptoms and functional impairment. The availability of Fetzimais a significant step forward in our goal of bringing a range of treatment options to adults living with MDD.”

Fetzimais a serotonin and norepinephrine reuptake inhibitor (SNRI). The efficacy of Fetzimawas established in three positive double-blind phase III studies comprising two fixed-dose studies and one flexible-dose study that compared Fetzimato 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 Fetzimadosage 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 Fetzimadoses (-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 Fetzimadoses 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 Fetzimadosing range studied (-3.1 at 40-120 mg/day).

Fetzimaalso demonstrated significant improvement in functional impairment as measured by the mean change from baseline in the Sheehan Disability Scale (SDS) total score. SDS is a validated, patient-rated scale used to assess functional impairment in the three domains of work/school, social life, and family life as a result of psychiatric symptoms.

The most commonly observed adverse reactions in MDD patients treated with Fetzimain placebo-controlled studies (incidence =5% and at least twice the rate of placebo) were nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations. Nine per cent of the 1583 patients who received Fetzima(40 mg - 120 mg) discontinued treatment due to an AE, compared with three per cent of the 1040 placebo-treated patients. The only dose-related AEs (>2%) in the fixed-dose studies were urinary hesitation and erectile dysfunction.

Levomilnacipran potently inhibits serotonin (5-HT) and norepinephrine reuptake (IC50=16-19 nM and 11 nM, respectively). Greater reuptake inhibition of norepinephrine over serotonin was shown in vitro.

Levomilnacipran lacks significant affinity for any other receptors, ion channels, or transporters tested in vitro, including serotonergic (5-HT1-7), a- and ß-adrenergic, muscarinic, or histaminergic receptors and Ca2+, Na+, K+, or Cl- channels.

Levomilnacipran was licensed to Forest Laboratories Inc. by Pierre Fabre, in the US and Canada. Pierre-Fabre will also be the active pharmaceutical ingredient (API) supplier.

Forest Laboratories is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market.