“Major depressive disorder can be disabling and can keep a person from functioning normally,” said Mitchell Mathis, M.D., 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.”
A total of six clinical studies were conducted to garner FDA’s drug approval. The trials compared Brintellix with a placebo in people with clinical depression. An additional study showed Brintellix decreased the likelihood of participants becoming depressed again after treatment of their depressive episode. These studies were conducted in the United States and other countries.
The most common side effects reported by participants taking Brintellix in clinical trials included nausea, constipation and vomiting. Overall, 5 to 8 percent of the patients who received Brintellix 5 to 20 mg/day in short-term trials discontinued treatment due to an adverse reaction, the most common being nausea, compared with 4 percent of placebo-treated patients in these studies.
According to the manufacturers of Brintellix, Takeda Pharmaceutical & H. Lundbeck, the mechanism of the antidepressant effect of Brintellix is not fully understood.
What is known is that the new drug is an inhibitor of serotonin (5-HT) reuptake, and also acts as an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of these activities to Brintellix’s antidepressant effect has not been established, but it is considered to be the first and only compound with this combination of pharmacodynamic activity.
“There are very few new antidepressant drugs currently in development even though so many patients still struggle with depression. We are excited about the approval of Brintellix and being able to offer a new option for patients,” said Anders Gersel Pedersen, executive vice president and head of research and development for Lundbeck.
Major depressive disorder (MDD), commonly referred to as depression or clinical depression, is an often serious 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.
Other signs and symptoms of MDD include loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. Not all people with MDD experience the same symptoms.
Brintellix will be available in 5 mg, 10 mg, 15 mg and 20 mg tablets.
Brintellix was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in the U.S. was conducted jointly by Lundbeck and Takeda, and Takeda holds the new drug application for the U.S. market.
Brintellix and other antidepressant drugs have a Boxed Warning and a Medication Guide alerting patients and healthcare professionals that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents and young adults ages 18 to 24 during initial treatment.
Studies show adults older than 24 years of age do not appear to have an increased risk of suicidal thoughts and behavior, while adults ages 65 and older appear to have a reduced risk. Patients starting antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior.