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FDA approves novel new antidepressant: Brintellix

2013-10-04 17:33
FDA approves Brintellix for treatment of depression

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.

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"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.

Other signs and symptoms of depression include loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping, restlessness or agitation, increased fatigue, feelings of worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. However, not everyone with depression experiences the same symptoms.

"Major depressive disorder can be disabling and can keep a person from functioning normally," said Mitchell Mathis, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression."

The most common side effects reported by participants taking Brintellix in clinical trials included nausea, constipation and vomiting.

Brintellix will be available in 5 mg, 10 mg, 15 mg and 20 mg tablets and is being co-marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, Ill.

SOURCE: U.S. Food and Drug Administration, Press Release: Takeda and Lundbeck Announce FDA Approval of BrintellixTM (vortioxetine) for Treatment of Adults with Major Depressive Disorder (October 1, 2013)