SAVELLA (milnacipran hydrochloride)
Savella treats fibromyalgia in adult patients. It helps patients with the chronic pain and various symptoms associated with this condition. This medication is not used for pediatric patients.
How SAVELLA Works
This drug works by inhibiting the reuptake of norepinephrine and serotonin, which is thought to improve central pain inhibition. It is approximately three times more potent at blocking norepinephrine reuptake than serotonin reuptake. It does not have a significant effect on other neurotransmitters or receptors, such as dopamine or histamine.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-01-14
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET
SAVELLA Approval History
What SAVELLA Treats
1 indicationsSAVELLA is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Fibromyalgia
SAVELLA Boxed 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, ado...
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 Indications and Usage ( 1 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. Increased risk of suicidal ideation, thinking, and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorder s ( 5.1 ) . SAVELLA is not approved for use in pediatric patients ( 1 , 8.4 ).
SAVELLA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SAVELLA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01826981 results posted | GS-US-337-0122 | Ph 2 | completed | Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection |
| NCT01909804 results posted | GS-US-342-0109 | Ph 2 | completed | Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection |
| NCT01858766 results posted | GS-US-342-0102 | Ph 2 | completed | Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection |
| NCT01221740 | 2010-P-00977/1 | Ph 3 | withdrawn | Pain Assessment and Quality of Life in Back Pain Patients: Role of Milnacipran |
| NCT01418651 | 10-007 | Ph 3 | terminated | Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SAVELLA FDA Label Details
Indications & Usage
FDA Label (PDF)SAVELLA is indicated for the treatment of Fibromyalgia.
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 beh...
SAVELLA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for SAVELLA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 16 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment