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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 (5.1), Use in Specific Populations (8.4) ]
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SAVELLA SUMMARY
Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin.
Savella is indicated for the management of fibromyalgia.
Savella is not approved for use in pediatric patients [ see Use in Specific Populations (8.4) ].
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NEWS HIGHLIGHTSMedia Articles Related to Savella (Milnacipran)
ACR: Drug Delivers Two-Fisted Punch to Fibromyalgia (CME/CE)
Source: MedPage Today Rheumatology [2009.10.23]
PHILADELPHIA (MedPage Today) -- Milnacipran (Savella) improved pain and mental functioning in patients suffering from fibromyalgia, researchers said here.
CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Pain / Anesthetics News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.
Promising Results In Reducing Neuropathic Pain With Combined Drug Treatment, Than With Either Drug Alone
Source: Body Aches News From Medical News Today [2009.09.30]
An article published Online First and in a future edition of The Lancet reports that combination treatment using gabapentin and nortriptyline reduces neuropathic pain more than either drug alone. This treatment could be used in patients that only partly respond to one drug or the other. The article is the work of Professor Ian Gilron, Director of Clinical Pain Research, Queen's University, and Kingston General Hospital, Kingston, Ontario, Canada, and colleagues.
NeurogesX To Hold Conference Call To Discuss FDA Approval Of Qutenza(TM) (capsaicin) 8% Patch For Treatment Of Postherpetic Neuralgia (PHN)
Source: Pain / Anesthetics News From Medical News Today [2009.11.18]
NeurogesX, Inc. (Nasdaq: NGSX) announces that it will hold a conference call at 8:30a.m. ET (5:30a.m. PT) to discuss the U.S. Food and Drug Administration (FDA) approval of Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles.
Gabapentin Studies for Off-Label Uses Cooked? (CME/CE, with audio)
Source: MedPage Today Neurology [2009.11.11]
Primary outcome measures were apparently a moving target in many company-sponsored studies of gabapentin (Neurontin) for off-label uses such as neuropathic pain and bipolar disorder, researchers have suggested.
Published Studies Related to Savella (Milnacipran)
The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial. [2009.02]
OBJECTIVE: To evaluate the safety and efficacy of milnacipran, a dual norepinephrine and serotonin reuptake inhibitor, in the treatment of fibromyalgia (FM)... CONCLUSION: Milnacipran is safe and effective for the treatment of multiple symptoms of FM.
Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. [2008.11]
BACKGROUND: Preclinical and clinical studies have suggested that milnacipran, a dual norepinephrine-serotonin reuptake inhibitor, may be efficacious in the treatment of fibromyalgia (FM). OBJECTIVE: This study was conducted to evaluate the efficacy and tolerability of milnacipran in treating the multiple domains of FM... CONCLUSION: In these adult patients with FM, both doses of milnacipran (100 and 200 mg/d) were associated with significant improvements in pain and other symptoms. Clinical Trials Identification Number: NCT00098124.
The alpha 2A-adrenergic receptor gene polymorphism modifies antidepressant responses to milnacipran. [2008.10]
CONCLUSIONS: The ADRA2A polymorphism could be a reasonable candidate to predict the response to milnacipran. Our results are still preliminary, and a large sample size will be required to confirm our findings. However, to the best of our knowledge, this study is the first to suggest a possible association of ADRA2A variants with the SNRI response.
Resolution of sexual dysfunction during acute treatment of major depression with milnacipran. [2008.08]
OBJECTIVE: The sexual function and enjoyment questionnaire (SFEQ) was developed to assess and detect changes in sexual function in men and women. The aim of the present study was to use the SFEQ to evaluate the effects of the serotonin-noradrenaline reuptake inhibitor, milnacipran, in the treatment of depression in two culturally different populations... CONCLUSIONS: Milnacipran appears to improve sexual function in parallel with improvement in other symptoms of depression. The SFEQ is a sensitive instrument for measuring changes in sexual function and appears to be unaffected by cultural differences as shown by similar findings in Brazil and Europe. (c) 2008 John Wiley & Sons, Ltd.
Effects of milnacipran and paroxetine on overactive bladder due to neurologic diseases: a urodynamic assessment. [2008]
AIMS: To determine the effects of milnacipran hydrochloride, a serotonin-norepinephrine reuptake inhibitor (SNRI), or paroxetine hydrochloride, a selective serotonin reuptake inhibitor, on overactive bladder (OAB) in neurologic diseases, given by objective measures of urodynamic studies... CONCLUSION: Milnacipran, an SNRI, increased bladder capacity as shown in urodynamic studies, and thereby ameliorated OAB in patients with neurologic diseases without serious adverse effects. 2008 S. Karger AG, Basel
Clinical Trials Related to Savella (Milnacipran)
Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran [Recruiting]
Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared
to placebo, in fibromyalgia out-patients
Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke? [Recruiting]
Depression is one of the important psychiatric sequelae after stroke. The prevalence of
post stroke depression (PSD) is approximately 20-40%. Depression comorbid with stroke has
been found to be associated with increased disability, cognitive function decline, poorer
rehabilitation outcome and higher mortality rate. We are going to conduct a trial of
prevention of psot stroke depression by prescribing milnacipran in advance.
Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients [Recruiting]
The purpose of this study is to determine whether pharmacogenomic study predict
antidepressant responsiveness in advance before the appearance of the drug effects until 4~6
weeks after drug administration.
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Page last updated: 2009-11-19
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