EXPERT OPINION Results of placebo-controlled trials suggest efficacy and an overall safety profile comparable to existing first-line antidepressants .
The most common side effects are nausea , vomiting and constipation .
Results of several studies indicate that vortioxetine may have therapeutic effects on cognition ( e.g. , memory and executive functioning ) that exceed that of st and ard antidepressants .
The authors suggest that vortioxetine is currently a good second-line antidepressant option and shows promise , pending additional long-term data , to become a first-line antidepressant option
INTRODUCTION Vortioxetine is a structurally novel medication that has recently been approved for treatment of major depressive disorder ( MDD ) .
This medication is a serotonin reuptake inhibitor that also has a number of other potentially relevant effects on serotoninergic receptors , which may differentiate the drug 's effects from those of current first-line antidepressants , such as selective serotonin reuptake inhibitors ( SSRIs ) and serotonin norepinephrine reuptake inhibitors ( SNRIs ) .
AREAS COVERED This article will review the basic clinical pharmacology of vortioxetine , summarize the major clinical trials that were performed prior to approval by the US Food and Drug Administration ( FDA ) , discuss relevant post-marketing studies of this drug , and offer expert commentary on the significance of this new agent in clinical practice .
Safety, tolerability, and efficacy of vortioxetine (Lu AA21004) in major depressive disorder: results of an open-label, flexible-dose, 52-week extension study
Patients with major depressive disorder often experience relapse after responding to treatment ; therefore , maintenance therapy with antidepressants is recommended for maintaining response or remission . This multicenter , open-label , flexible-dose , 52-week extension study evaluated the long-term safety , tolerability , and maintenance of efficacy in study participants who had completed one of two r and omized , double-blind , placebo-controlled , 8-week dose-ranging vortioxetine trials in study participants with major depressive disorder . At the open-label baseline , all study participants were switched to vortioxetine 5 mg/day for the first week , with subsequent dose adjustments from 2.5 to 10 mg/day on the basis of response and tolerability . Treatment with vortioxetine for 52 weeks was well tolerated , with no new safety signals identified . Among the 834 evaluable study participants , treatment-emergent adverse events were reported in 70.6 % , with the most common in the combined ( all doses ) population of nausea ( 15.2 % ) , headache ( 12.4 % ) , nasopharyngitis ( 9.8 % ) , diarrhea ( 7.2 % ) , and dizziness ( 6.8 % ) . The rate of adverse events related to sexual dysfunction was low and weight gain was minimal . Laboratory values , vital signs , ECGs , physical examinations , and Columbia-Suicide Severity Rating Scale results showed no trends of clinical concern . The change in the severity of depressive and anxiety symptoms was maintained throughout the study as reflected by a 24-item Hamilton Depression Scale total score of 8.2 at week 52 ( from 17.6 at open-label baseline ) in the observed case data set
EXPERT OPINION Results of placebo-controlled trials suggest efficacy and an overall safety profile comparable to existing first-line antidepressants .
The most common side effects are nausea , vomiting and constipation .
Results of several studies indicate that vortioxetine may have therapeutic effects on cognition ( e.g. , memory and executive functioning ) that exceed that of st and ard antidepressants .
The authors suggest that vortioxetine is currently a good second-line antidepressant option and shows promise , pending additional long-term data , to become a first-line antidepressant option
INTRODUCTION Vortioxetine is a structurally novel medication that has recently been approved for treatment of major depressive disorder ( MDD ) .
This medication is a serotonin reuptake inhibitor that also has a number of other potentially relevant effects on serotoninergic receptors , which may differentiate the drug 's effects from those of current first-line antidepressants , such as selective serotonin reuptake inhibitors ( SSRIs ) and serotonin norepinephrine reuptake inhibitors ( SNRIs ) .
AREAS COVERED This article will review the basic clinical pharmacology of vortioxetine , summarize the major clinical trials that were performed prior to approval by the US Food and Drug Administration ( FDA ) , discuss relevant post-marketing studies of this drug , and offer expert commentary on the significance of this new agent in clinical practice .