FDA Grants Breakthrough Tx Designation to Novel Antidepressant

FDA Grants Breakthrough Tx Designation to Novel Antidepressant
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.

RELATED: Preliminary Results for Investigational MDD Tx Announced 

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.

For more information call (800) 433-8871 or visit Allergan.com.

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