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Label indication FETZIMA ® is indicated for the treatment of major depressive disorder (MDD) in adults [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. FDA label
Also known as Levomilnacipran ER
Levomilnacipran · 1 trial · 1 indication
The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years. It contains 17 ordinally-scaled items that evaluate the presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
| Arm | Type | Description |
|---|---|---|
| Levomilnacipran ER 40-80 mg/day | EXPERIMENTAL | Levomilnacipran extended release (ER) capsules, orally, 10 milligram per day (mg/day) on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by levomilnacipran ER 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period. |
| Fluoxetine 20 mg/day | ACTIVE_COMPARATOR | Fluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by fluoxetine 10 mg/day from Day 1 through Day 7 of the Down-taper Period. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period and Days 1 through 7 in the Down-taper Period. |
| Name | Type | Description |
|---|---|---|
| Levomilnacipran ER | DRUG | Levomilnacipran extended-release oral capsules |
| Fluoxetine | DRUG | Fluoxetine oral capsules |
| Placebo | DRUG | Matching placebo oral capsules |
Inclusion Criteria: * Patients must meet Diagnostic and statistical manual of mental disorders fifth edition (DSM-5) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders - Present and Lifetime (K-SADS-PL) * Patients must have a score ≥ 40 on the Children's Depression Rating Scale-...
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Levomilnacipran is being studied for the treatment of major depressive disorder, a psychiatric condition. It is a small molecule developed by AbbVie Inc. under the ticker ABBV. The clinical program has focused on major depressive disorder, including a Phase 3 trial in pediatric patients aged 7 to 17 years.
Levomilnacipran targets SLC6A4 and SLC6A2, which are the serotonin transporter and the norepinephrine transporter. It acts as an inhibitor of these transporters. This target profile places it in the antidepressant class of small molecule agents studied for major depressive disorder.
Levomilnacipran is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the clinical development program for this small molecule in major depressive disorder. The program includes a completed Phase 3 trial conducted in the United States.
Levomilnacipran is in Phase 3 development for major depressive disorder. It is an investigational small molecule and is not described as approved. The Phase 3 program includes one completed trial, and no trials are currently listed as active.
Levomilnacipran has been evaluated in the Phase 3 trial NCT03569475, titled Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder. That trial is completed, enrolled 501 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States.
Yes, Levomilnacipran ER is an alternative name for Levomilnacipran. The ER designation refers to the extended release form used in the clinical program. The Phase 3 trial NCT03569475 studied Levomilnacipran ER in pediatric patients aged 7 to 17 years with major depressive disorder.