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Vortioxetine, a novel antidepressant, has been approved for treating major depressive disorder in adults.
It will be marketed as Brintellix, by Takeda Pharmaceuticals and Lundbeck, and will be available in 5-mg, 10-mg, 15-mg, and 20-mg tablets. The Food and Drug Administration approved the drug Oct. 1.
The prescribing information and the Takeda/Lundbeck press release announcing the approval include the statement that the mechanism of vortioxetine’s antidepressant effect "is not fully understood."
"But it is thought to be related to its enhancement of serotonergic activity in the [central nervous system] through inhibition of the reuptake of serotonin (5-HT)," according to the prescribing information. The prescribing information adds: "It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine’s antidepressant effect has not been established."
In the FDA’s statement, Dr. Mitchell Mathis said that since medications affect everyone differently, "it is important to have a variety of treatment options available for patients who suffer from depression." Dr. Mathis is acting director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research.
Approval was based on six short-term, 6- to 8-week, randomized studies conducted in the United States and elsewhere, which found that treatment with at least one dose of the drug was more effective than placebo in improving depression symptoms. Five of the studies enrolled patients aged 18-75 years, and one enrolled patients aged 64-88 years.
In a long-term maintenance study, those treated with vortioxetine had a longer time to recurrence of depression than did those treated with placebo, a difference that was statistically significant. Nausea, vomiting, and constipation were the most common adverse effects associated with the drug in clinical trials, according to the FDA statement.
As with all antidepressant drugs, the prescribing information has a boxed warning and medication guide about the increased risk of suicidal thoughts and behavior in children, adolescents, and adults aged 18-24 years, during initial treatment. The warning includes the recommendation that people starting treatment with antidepressants be closely monitored for worsening depression and suicidal thoughts and behavior.
The drug is expected to be available in the United States by the end of 2013, according to Takeda. It has been submitted for approval in Europe.
Vortioxetine, a novel antidepressant, has been approved for treating major depressive disorder in adults.
It will be marketed as Brintellix, by Takeda Pharmaceuticals and Lundbeck, and will be available in 5-mg, 10-mg, 15-mg, and 20-mg tablets. The Food and Drug Administration approved the drug Oct. 1.
The prescribing information and the Takeda/Lundbeck press release announcing the approval include the statement that the mechanism of vortioxetine’s antidepressant effect "is not fully understood."
"But it is thought to be related to its enhancement of serotonergic activity in the [central nervous system] through inhibition of the reuptake of serotonin (5-HT)," according to the prescribing information. The prescribing information adds: "It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine’s antidepressant effect has not been established."
In the FDA’s statement, Dr. Mitchell Mathis said that since medications affect everyone differently, "it is important to have a variety of treatment options available for patients who suffer from depression." Dr. Mathis is acting director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research.
Approval was based on six short-term, 6- to 8-week, randomized studies conducted in the United States and elsewhere, which found that treatment with at least one dose of the drug was more effective than placebo in improving depression symptoms. Five of the studies enrolled patients aged 18-75 years, and one enrolled patients aged 64-88 years.
In a long-term maintenance study, those treated with vortioxetine had a longer time to recurrence of depression than did those treated with placebo, a difference that was statistically significant. Nausea, vomiting, and constipation were the most common adverse effects associated with the drug in clinical trials, according to the FDA statement.
As with all antidepressant drugs, the prescribing information has a boxed warning and medication guide about the increased risk of suicidal thoughts and behavior in children, adolescents, and adults aged 18-24 years, during initial treatment. The warning includes the recommendation that people starting treatment with antidepressants be closely monitored for worsening depression and suicidal thoughts and behavior.
The drug is expected to be available in the United States by the end of 2013, according to Takeda. It has been submitted for approval in Europe.
Vortioxetine, a novel antidepressant, has been approved for treating major depressive disorder in adults.
It will be marketed as Brintellix, by Takeda Pharmaceuticals and Lundbeck, and will be available in 5-mg, 10-mg, 15-mg, and 20-mg tablets. The Food and Drug Administration approved the drug Oct. 1.
The prescribing information and the Takeda/Lundbeck press release announcing the approval include the statement that the mechanism of vortioxetine’s antidepressant effect "is not fully understood."
"But it is thought to be related to its enhancement of serotonergic activity in the [central nervous system] through inhibition of the reuptake of serotonin (5-HT)," according to the prescribing information. The prescribing information adds: "It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine’s antidepressant effect has not been established."
In the FDA’s statement, Dr. Mitchell Mathis said that since medications affect everyone differently, "it is important to have a variety of treatment options available for patients who suffer from depression." Dr. Mathis is acting director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research.
Approval was based on six short-term, 6- to 8-week, randomized studies conducted in the United States and elsewhere, which found that treatment with at least one dose of the drug was more effective than placebo in improving depression symptoms. Five of the studies enrolled patients aged 18-75 years, and one enrolled patients aged 64-88 years.
In a long-term maintenance study, those treated with vortioxetine had a longer time to recurrence of depression than did those treated with placebo, a difference that was statistically significant. Nausea, vomiting, and constipation were the most common adverse effects associated with the drug in clinical trials, according to the FDA statement.
As with all antidepressant drugs, the prescribing information has a boxed warning and medication guide about the increased risk of suicidal thoughts and behavior in children, adolescents, and adults aged 18-24 years, during initial treatment. The warning includes the recommendation that people starting treatment with antidepressants be closely monitored for worsening depression and suicidal thoughts and behavior.
The drug is expected to be available in the United States by the end of 2013, according to Takeda. It has been submitted for approval in Europe.
