FDA Grants Breakthrough Tx Designation to Novel Antidepressant

Allergan announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational drug rapastinel (GLYX-13) for the adjunctive treatment of Major Depressive Disorder (MDD).

The designation was supported by preclinical and preliminary clinical evidence from Phase 2 studies in patients with MDD who had inadequate response to ≥1 antidepressants. Rapastinel was shown to have a rapid (within 1 day) onset and sustained antidepressant effect. Rapastinel was also found to have a tolerable safety profile, with no psychotomimetic or hallucinogenic side effects observed.

The FDA previously granted Fast Track designation to rapastinel in 2014. Allergan intends to initiate Phase 3 studies for rapastinel some time this year.

Rapastinel is an investigational intravenous formulation of a novel NMDA receptor partial agonist.

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