Lundbeck Korea said it would conduct a phase-3 clinical trial on antidepressant Brintellix (ingredient: vortioxetine) for pediatric patients with a major depressive disorder in Korea.
The Ministry of Food and Drug Safety recently approved the trial plan, which will assess the efficacy of Brintellix 10mg, 15mg, and 20mg on 12 patients aged between 12 and 17.
The local trial is part of the drugmaker’s global study of the drug in adolescents aged 12 to 17 years with a major depressive disorder. The study is interventional, randomized, double-blind, placebo-controlled, active reference (fluoxetine), and fixed-dose.
Jointly developed by Lundbeck and Takeda, Brintellix arrived in Korea in 2015 as an antidepressant with multiple action mechanisms.
Existing antidepressants use SSRIs (selective serotonin reuptake inhibitor) and SNRIs (serotonin-norepinephrine reuptake inhibitor) to help the body maintain a certain level of serotonin to reduce depression.
However, Brintellix directly controls the receptor of serotonin, as well as inhibits serotonin reuptake. The drug prompts the activity of various neurotransmitters to balance the neurotransmitters in the brain, which is effective in patients who do not respond sufficiently to conventional antidepressants. It improved existing antidepressants’ significant adverse effects such as sexual dysfunction, weight gain, and sleep disorder.
Brintellix proved its antidepressant efficacy in clinical trials in more than 9,500 patients worldwide. It showed an improvement in cognitive function in patients with the major depressive disorder.
Earlier, Lundbeck had pushed a clinical trial to add to Brintellix an indication of adult ADHD (attention deficit hyperactive disorder) and cognitive dysfunction but failed to get the additional approval of the U.S. Food and Drug Administration for the indication in 2016.
In Korea, Brintellix prescriptions started to rise since the health authorities changed the reimbursement condition to allow patients with particular neurological disorders such as dementia to take SSRI antidepressants for more than 60 days from Jan. 1, 2017.
Brintellix is expected to have posted 1.4 billion won ($1.3 million) in prescription sales last year, according to U-BIST’s estimate.
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