The standard boxed warning about a potential connection will be required for suicide effects with the drug. The drug contains a serotonin modulator and stimulator element which is supposed to make the drug more effective than current products on the market which is said to separate it from being a “me too”.
Just in time to treat our economic depression woes….BD
The Food and Drug Administration late Monday 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 chemical name is vortioxetine, is to be marketed under the commercial name Brintellix.
Brintellix received the agency's approval without deliberation by a science advisory panel, a public review of an investigative drug's safety and effectiveness. In announcing its decision, the FDA said the new medication was found "effective in treating depression" in six clinical trials that compared outcomes in subjects taking the drug against those of subjects who received a sham medication, or placebo.
Not included in the FDA's announcement were benefits the drug's developers had hoped to tout to potential prescribers and patients. As a "serotonin modulator and stimulator," vortioxetine influences the availability of the neurotransmitter serotonin by five different mechanisms. The developers had argued that by increasing its modes of action above and beyond those of standard SSRI medications known by such commercial names as Prozac, Lexapro, Zoloft and Paxil, this new medication might represent an improvement on those drugs.