FDA approves novel new antidepressant: Brintellix
On Monday, the Food and Drug Administration (FDA) approved the antidepressant Brintellix, a novel variant on the selective serotonin reuptake inhibitors (SSRIs) that have become popular medications for the treatment of depression.
Brintellix, whose generic chemical name is vortioxetine, is being touted as having benefits over other antidepressants because vortioxetine is a "serotonin modulator and stimulator" that influences the availability of the neurotransmitter serotonin by five different mechanisms.
By increasing its modes of action above and beyond those of standard SSRI drugs, such as Prozac, Lexapro, Zoloft and Paxil, the makers of Brintellix say the new medication stands to be an improvement over other SSRI antidepressants from the past.
Another benefit of vortioxetine is that it may improve some aspects of memory in addition to alleviating depressive symptoms. For example, one study of humans found that those taking vortioxetine had better cognitive function than those taking the antidepressant duloxetine, sold under the brand-name Cymbalta.
And in another clinical trial that compared those taking vortioxetine with others taking the antidepressant venlafaxine (brand-name Effexor), found that those taking vortioxetine suffered less sexual dysfunction.
However, the FDA has declined to approve such claims for the new drug until they can be replicated and extended by further research.
"These hopes, of course, remain to be proven," said Dr. Michael Thase, a University of Pennsylvania psychiatrist and psychopharmacologist who consulted on the development of the drug.
"It is different enough" from the welter of SSRIs currently available "that it's not simply a 'me too' drug," he added.
"At the least, you will have a drug with some different effects – different ways in which it interacts with the brain" to ease depression, he said. "At the most, it will be useful and will become one of our favorite antidepressants. But that typically takes several years to evolve."
Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mood changes and other symptoms that interfere with a person's ability to work, sleep, study, eat and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime, although some may experience a single occurrence.