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Related Experiment Video

Updated: May 8, 2026

Vagus Nerve Stimulation As an Adjunctive Neurostimulation Tool in Treatment-resistant Depression

Vagus Nerve Stimulation As an Adjunctive Neurostimulation Tool in Treatment-resistant Depression

Published on: January 7, 2019

Levomilnacipran extended release: first global approval.

Philip Hair¹, Fiona Cameron, Karly P Garnock-Jones

¹Adis R & D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand, dru@adis.com.

|September 4, 2013

Summary

Levomilnacipran extended release (ER) is a novel treatment for major depressive disorder (MDD). This enantiomer of milnacipran selectively targets norepinephrine and serotonin reuptake, offering a new therapeutic option.

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Area of Science:

Pharmacology
Neuroscience
Drug Development

Background:

Levomilnacipran extended release (ER) is an enantiomer of milnacipran developed for major depressive disorder (MDD).
It selectively inhibits norepinephrine and serotonin reuptake, neurotransmitters crucial for mood regulation.
The drug is formulated as an extended-release capsule for once-daily administration.

Purpose of the Study:

To summarize the key milestones in the development of levomilnacipran ER.
To highlight its journey leading to the initial approval for treating major depressive disorder (MDD).

Main Methods:

Review of clinical trial phases (Phase II and III) for major depressive disorder (MDD).
Examination of development progress in the US, Canada, and Europe.
Consideration of trials for fatigue associated with MDD and functional recovery post-ischaemic stroke.

Main Results:

Levomilnacipran ER is approved and launched in the US for MDD treatment.
Phase III development for MDD completed in the US and Canada.
Phase II trials for MDD and MDD-associated fatigue completed; development for ischaemic stroke recovery is ongoing in Europe.

Conclusions:

Levomilnacipran ER has successfully achieved regulatory approval for major depressive disorder (MDD) in the US.
The drug's development pathway demonstrates its potential in treating mood disorders and neurological recovery.