FDA approves new antidepressant

The Food and Drug Administration approved a new antidepressant medication that is a novel variant on the selective serotonin reuptake inhibitors, or SSRIs, that have become the mainstay of depression treatment. The drug, whose generic name is vortioxetine, is to be marketed under the name Brintellix.

Brintellix received the agency’s approval Sept. 30. The FDA said the new medication was found “effective in treating depression” in six clinical trials.

The agency also cited a clinical trial that found among those taking Brintellix a decreased likelihood of becoming clinically depressed after successful treatment.

Like SSRIs and a range of older antidepressant medications, Brintellix will carry a boxed warning alerting patients and physicians that with children, adolescents and young adults between 18 and 24, antidepressants can increase the risk of suicidal thoughts and behavior.

Not included in the FDA’s announcement were benefits developers had hoped to tout. As a “serotonin modulator and stimulator,” vortioxetine influences the availability of the neurotransmitter serotonin by five mechanisms. The developers had argued that by increasing its modes of action above and beyond those of standard SSRI medications, this new medication might represent an improvement on those drugs.

The drug developer submitted early research – conducted on rats – suggested vortioxetine may improve some dimensions of memory. A trial in human subjects showed those taking vortioxetine had better cognitive function than those taking duloxetine (marketed as Cymbalta). A single clinical trial found that compared to subjects taking venlafaxine (marketed as Effexor), those taking vortioxetine suffered less sexual dysfunction.

The FDA declined to approve such claims for the new drug until they were replicated.