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Savella (Milnacipran Hydrochloride) - Summary

 
 



WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients [see Warnings and Precautions (), Use in Specific Populations ()]. 5.1 8.4

 

SAVELLA SUMMARY

Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical name: (┬▒)-[1R(S),2S(R)]-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride.

Savella is indicated for the management of fibromyalgia.

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


See all Savella indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Savella (Milnacipran)

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.

Dual reuptake inhibitor milnacipran and spinal pain pathways in fibromyalgia patients: a randomized, double-blind, placebo-controlled trial. [2013]
SETTING: A single academic medical center, outpatient setting... CONCLUSION: Milnacipran has a predominantly supraspinal analgesic effect as

Prevention of poststroke depression with milnacipran in patients with acute ischemic stroke: a double-blind randomized placebo-controlled trial. [2011.09]
Poststroke depression (PSD) is one of the most frequent neuropsychiatric consequences of stroke. It has been shown to be associated with both impaired recovery and increased mortality... In conclusion, milnacipran could prevent the development of depression in the first year following a stroke and is safe to use without significant adverse effects in stroke patients.

The dubious effect of milnacipran for the treatment of burning mouth syndrome. [2011.07]
OBJECTIVE: Burning mouth syndrome (BMS) is a condition accompanied by oral burning symptoms, including glossal pain (glossodynia) without a detectable cause. Although BMS is a chronic-pain syndrome, only one self-controlled pilot study and some case reports have reported that milnacipran is effective for the treatment of chronic pain, including that caused by BMS. However, these papers assessed only pain, and the dosage of prescribed milnacipran varied from 30 to 150 mg/d in each patient. In this study, the dosage of prescribed milnacipran was set at 60 mg/d for 12 weeks for all patients, and depression and quality of life (QOL) were assessed in addition to pain... CONCLUSIONS: A randomized, double-blind, placebo-controlled multi-institution trial of milnacipran will be essential to determine its effectiveness for the treatment of BMS.

The dubious effect of milnacipran for the treatment of burning mouth syndrome. [2011]
(QOL) were assessed in addition to pain... CONCLUSIONS: A randomized, double-blind, placebo-controlled multi-institution

more studies >>

Clinical Trials Related to Savella (Milnacipran)

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.

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 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.

The Savella Pregnancy Registry [Recruiting]
The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up registry designed primarily to estimate the prevalence of major congenital anomalies, and secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Savella as well as adverse outcomes observed during the first year of life in off-springs born from these exposed pregnancies. Live offspring are followed from birth until age one. The Savella Pregnancy Registry is sponsored by Actavis plc (formerly Forest Laboratories Inc.) and managed by INC Research, LLC.

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 >>

Reports of Suspected Savella (Milnacipran) Side Effects

Nausea (47)Headache (33)Insomnia (24)Vomiting (23)Hyperhidrosis (22)Pain (21)Blood Pressure Increased (21)Dizziness (20)Depression (20)Heart Rate Increased (18)more >>


Page last updated: 2015-08-10

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