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Transcript of Fetzima (levomilnacipran)
Adverse Drug Reactions
Increased Heart Rate
Efficacy and Safety of Levomilnacipran Sustained Release 40 mg, 80 mg, or 120 mg in Major Depressive Disorder: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Levomilnacipran may be a good treatment option for patients 18-65 who suffer from MDD and would benefit from an improvement in depressive and functional impairments.
Presented by: Cheri Grant, PharmD Candidate
Purdue University, College of Pharmacy
October 9, 2013
Approved by the FDA July 2013 to treat Major Depressive Disorder (MDD)
MOA- SNRI that increases extracellular concentrations of serotonin and norepinephrine
SR capsule available in 20, 40, 80, and 120 mg strengths
Initiation of Therapy
Levomilnacipran should be started at 20 mg daily for 2 days, then increased in increments of 40 mg at intervals of 2 or more days
Must swallow whole
CrCl > 60 mL/min no dose adjustments needed
CrCl 30-59 mL/min do not exceed 80 mg/day
CrCl 15-29 mL/min do not exceed 40 mg/day
CrCl < 15 mL/min not recommended
Discontinuation of Therapy
Gradual dose reduction is recommended to prevent discontinuation syndrome.
Increased heart rate
Black Box Warning:
Increased Risk of suicidal thoughts in children, adolescents, and young adults
Dose adjustments are needed if levomilnacipran is used concurrently with a strong CYP3A4 inhibitor.
Protease inhibitors (ex: ritonavir)
Hypersensitivity to levomilnacipran or milnacipran HCL
Use of MAOIs within 7 days of stopping levomilnacipran
Use of levomilnacipran within 14 days of stopping MAOIs
Patients with uncontrolled narrow-angle glaucoma
increased risk of mydriasis
Multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 11 week phase 3 clinical trial.
38 US study centers
(September 2009 - May 2011)
724 pts randomized 1:1:1:1
Safety, efficacy, tolerability compared to placebo
Considered to have MDD defined by the DSM IV and confirmed by the mini-international neuropsychiatric interview
Current depressive episode ongoing ≥ 8 weeks
Score of ≥ 30 on clinician rated Montgomery–Åsberg Depression Rating Scale (MADRS)
Score ≥ 26 on self-rated MADRS
BMI ≥ 18 and ≤ 40
Negative pregnancy test results
Patients with significant medical conditions (ex: CNS disorders or CVD)
Clinically significant abnormalities: lab tests, or ECGs
DSM-IV axis I diagnoses other than MDD
Lifetime history of manic/hypomanic episodes
Substance abuse or dependence < 6 months
Non-response to ≥ 2 antidpressants
Concurrent use of psychoactive medicines ( except eszpoiclone, zolpidem, or zaleplon)
Common adverse effects that emerged during the treatment period of this trial included HA, nausea, constipation, dry mouth, increased heart rate, and hyperhidrosis.
More patients discontinued levomilnacipran compared to placebo due to these common adverse effects.
Nausea (placebo: 0, 40 mg: 1.1%, 80 mg: 3.4%, 120 mg: 0)
Vomiting (placebo: 0, 40 mg 0.6%, 80 mg: 1.7%, 120 mg: 0)
Palpitations (placebo: 0, 40 mg: 0, 80 mg: 1.7 %, 120 mg: 0)
No deaths occurred during this study
Side effects were tolerable and mild in intensity
Nasopharyngitis occurred more frequently during the 2 week down-taper period when in the levomilancipran group.
The incidence of suicidal ideation/behavior was similar among all treatment groups
This study demonstrated the efficacy and safety of levomilnacipran in patients with MDD without showing a dose-response tolerability.
The primary endpoint:
Change from baseline in the MADRS total score.
The secondary endpoint:
Change in baseline in the Sheehan Disability Scale (SDS) total score.
Other endpoints included:
17-item Hamilton Depression Rating Scale (HDRS17)
Clinical Global Impressions-Severity of Illness (CGI-S) and improvement (CGI-I)
At the end of 8 weeks the mean change in MADRS total score was -14.8, -15.6, -16.5, and -11.6 for the levomilnacipran 40 mg, 80 mg, 120 mg , and placebo respectively.
Significant advantages over placebo seen by week 4 in the 80 mg and 120 mg treatment groups with a p-value < 0.05 vs placebo.
At the end of 8 weeks the mean change in the SDS total score was -8.6, -9.7, -9.7 and -7.2 for levomilnacipran 40 mg, 80 mg, 120 mg, and placebo respectively
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