Travivo (gepirone ER; GlaxoSmithKline/Mission Pharmacal) is a pyridinyl piperazine 5-HT1A receptor agonist, and is distinct from available therapies as it is not a reuptake inhibitor and has no material norepinephrine or dopamine activity. Unlike tricyclic antidepressants or selective serotonin reuptake inhibitors that act on most or all of the 5-HT subtypes in the brain and may have several adverse effects, trials for Travivo have shown benign adverse effects without significant dopaminergic effects.
Travivo (gepirone ER; GlaxoSmithKline/Mission Pharmacal) appears to have weak prospects in the depression market. The drug has a lengthy history of regulatory obstacles, and its expected New Drug Application (NDA) amendment is shrouded with uncertainty given that the US Food and Drug Administration (FDA) appears divided on its approvability due to mixed trial data. Hence, Datamonitor Healthcare does not forecast Travivo’s approval. An interviewed US key opinion leader also highlighted the lack of novelty of its mechanism of action, which limits its potential.
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