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Drugs
Published in: Drugs 14/2013

01-09-2013 | R&D Insight Report

Levomilnacipran Extended Release: First Global Approval

Authors: Philip Hair, Fiona Cameron, Karly P. Garnock-Jones

Published in: Drugs | Issue 14/2013

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Abstract

Pierre Fabre and Forest Laboratories are developing levomilnacipran extended release (ER) [FETZIMA™], an enantiomer of milnacipran, for the treatment of major depressive disorder (MDD). In addition, Pierre Fabre (the originator of the compound) is developing the drug to improve recovery in patients with ischaemic stroke. Levomilnacipran ER exerts its effects by selectively inhibiting the reuptake of norepinephrine and serotonin (two neurotransmitters known to play an essential role in regulating mood) without directly affecting the uptake of dopamine or other neurotransmitters. The agent is being developed as an extended-release capsule formulation for once-daily dosing. Levomilnacipran ER is approved and launched in the US for the treatment of MDD; phase III development in this indication was completed in the US and Canada. In Europe, a phase II trial for MDD was completed, and development is in progress for improving functional recovery of patients with ischaemic stroke. A completed phase II trial in the US investigated levomilnacipran ER for the treatment of fatigue associated with MDD. This article summarizes the milestones in the development of levomilnacipran ER leading to the first approval for major depressive disorder.
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Metadata
Title
Levomilnacipran Extended Release: First Global Approval
Authors
Philip Hair
Fiona Cameron
Karly P. Garnock-Jones
Publication date
01-09-2013
Publisher
Springer International Publishing
Published in
Drugs / Issue 14/2013
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-013-0116-1

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