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Fetzima (Levomilnacipran Hydrochloride) - Summary

 
 



WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ].

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions].

FETZIMA is not approved for use in pediatric patients [see Use in Specific Populations].

 

FETZIMA SUMMARY

The active ingredient of FETZIMA is levomilnacipran, which is a selective serotonin and norepinephrine reuptake inhibitor (SNRI).

FETZIMA, a serotonin and norepinephrine reuptake inhibitor (SNRI) is indicated for the treatment of major depressive disorder (MDD). The efficacy of FETZIMA was established in three 8-week, randomized, double-blind, placebo-controlled studies in adult patients with a diagnosis of MDD [see Clinical Studies (14)].

Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.


See all Fetzima indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Fetzima (Levomilnacipran)

Efficacy of levomilnacipran extended-release in improving functional impairment associated with major depressive disorder: pooled analyses of five double-blind, placebo-controlled trials. [2014]
Major depressive disorder (MDD) is characterized by increased rates of impaired function and disability. During antidepressant treatment, functional improvement often lags behind symptomatic resolution, and residual impairment is associated with an increased risk for relapse... Similarly, functional impairment was significantly improved and higher functional and combined response and remission rates were achieved with levomilnacipran ER compared with placebo regardless of the baseline level of functional impairment.

more studies >>

Clinical Trials Related to Fetzima (Levomilnacipran)

The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia [Completed]
Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The proposed study is aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is randomized, double-blind, placebo controlled, two way crossover PSG study to explore the effects of milnacipran on sleep disturbance. Patients will receive either milnacipran 50 mg BID or matching placebo.

Milnacipran (Savella) in Irritable Bowel Syndrome (IBS) [Terminated]
Purpose: The investigators are proposing to examine the use of Savella« (Milnacipran) for treating irritable bowel syndrome (IBS) in women. Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS. Procedures: This study will observe patients treated with Savella« as well as patients treated with a placebo (pill with no active drug). The investigators will monitor and compare several patient and symptom related outcomes, as well as evaluate health related quality of life, psychological distress and related psychosocial measures to determine if the addition of Savella┬« improves clinical pain response as well as secondary outcomes including quality of life.

Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis [Completed]
The purpose of this study is to determine whether milnacipran reduces widespread, non-joint pain in patients with rheumatoid arthritis (RA). The investigators will conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis that milnacipran improves widespread, non-joint pain. The investigators will also use data from the trial to determine whether response to milnacipran is associated with pain-modulating mechanisms from the central nervous system. The investigators hypothesize that response to milnacipran will be greater among patients with impaired central pain mechanisms than among patients with intact central pain modulating mechanisms.

A Multicenter, Relapse Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder [Recruiting]
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse (MDD).

Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia [Completed]
The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

more trials >>


Page last updated: 2015-08-10

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