Depression Therapy Brintellix (Vortioxetine) Gets FDA Nod
Drug treats major depressive disorder (September 30)
The FDA has approved Brintellix (vortioxetine, Takeda Pharmaceuticals/Lundbeck) for the treatment of adults with major depressive disorder (MDD).
MDD 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 only a single occurrence.
Six clinical studies in which adults with MDD were randomly assigned to receive vortioxetine or placebo demonstrated that vortioxetine is effective in treating depression. An additional study showed that vortioxetine decreased the likelihood of participants becoming depressed again after treatment of their MDD episode.
The most common side effects reported by participants taking vortioxetine in clinical trials included nausea, constipation, and vomiting.
The drug will be available in 5-mg, 10-mg, 15-mg, and 20-mg tablets.
Brintellix (vortioxetine) and other antidepressant treatments have a boxed warning and a medication guide alerting patients and health care professionals that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults aged 18 to 24 years during initial treatment. Studies have shown that adults older than 24 years of age do not appear to have an increased risk of suicidal thoughts and behavior, while adults aged 65 years and older appear to have a reduced risk.
Source: FDA; September 30, 2013.