NDAORALTABLET
Approved
Jan 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Data completeness
7/8 — Comprehensive
SAVELLA (milnacipran hydrochloride) by AbbVie is unknown. Approved for fibromyalgia (). First approved in 2009.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SAVELLA (milnacipran HCl) is an oral small-molecule serotonin-norepinephrine reuptake inhibitor (SNRI) approved for fibromyalgia treatment. It works by inhibiting neuronal reuptake of norepinephrine and serotonin, with approximately 3-fold higher potency for norepinephrine, to alleviate fibromyalgia pain and symptoms. The mechanism of clinical efficacy in fibromyalgia remains incompletely understood, though preclinical data support dual monoamine reuptake inhibition without direct dopaminergic activity.
$0.061BPart D
Peak3.2 years to LOEProduct is at peak lifecycle stage with modest Medicare utilization ($61M Part D spending); commercial team focus is on maintaining market position rather than expansion.
Mechanism of Action
unknown. Preclinical studies have shown that milnacipran is a potent inhibitor of neuronal norepinephrine and serotonin reuptake; milnacipran inhibits norepinephrine uptake with approximately 3-fold higher potency in vitro than serotonin without directly affecting the uptake of dopamine or other…
Indications (1)
Clinical Trials (1)
The Savella Pregnancy Registry
Started Nov 2009
350 enrolled
Fibromyalgia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.