The United States Food and Drug Administration approved Brintellix for treatment of major depressive disorder Monday, bringing brand name options back to a drug market awash in generics.
Major depressive disorder (MDD), commonly referred to as depression, is defined as 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.
Brintellix, marketed by Lundbeck and Takeda Pharmaceuticals, is the brand name for the chemical name vortioxetine. The FDA news release listed nausea, constipation and vomiting as the most common side effects reported in clinical trials. The new depression drug is reported to be available in 5 mg, 10 mg, 15 mg and 20 mg tablets.
According to the developers, their drug represents an improvement over standard standard serotonin reuptake inhibitors (SSRI), medications available under the brand names Prozac, Lexapro, Zoloft and Paxil, available under generic names fluoxetine, escitalopram, sertraline and paroxetine.
“Major depressive disorder can be disabling and can keep a person from functioning normally,” said Dr. Mitchell Mathis, the 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 release states that Brintellix was demonstrated to be effective for treating adults with major depressive disorder in six clinical trials, in which adults with MDD were randomly assigned to receive Brintellix or placebo. An additional study showed Brintellix decreased the likelihood of participants becoming depressed again after treatment of their MDD episode. These studies were conducted in the United States and other countries.
According to PharmaTimes, major-market sales in the unipolar depression market are set to decline 30 percent during the next decade due to the availability of generic forms of Lexapro, Abilify and Cymbalta.
The L.A. Times reports that Brintellix brings other benefits to the table, although they did not appear in the FDA release. The developers submitted early research – conducted on rats – that suggested vortioxetine may improve some dimensions of memory.
“It is different enough [from the SSRIs currently available] that it’s not simply a ‘me too’ drug,” said Dr. Michael Thase, a University of Pennsylvania psychiatrist and psychopharmacologist who consulted on the development of the drug.
“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.”