Lundbeck and partner Takeda are celebrating after regulators in the USA gave the green light to their antidepressant Brintellix.
The US Food and Drug Administration has approved Brintellix (vortioxetine) to treat adults with major depressive disorder. The thumbs-up is based on six clinical studies which demonstrated that the drug is effective in treating depression. An additional trial showed Brintellix decreased the likelihood of participants becoming depressed again after treatment of their MDD episode.
The most common side effects reported by participants taking Brintellix, which will be available in 5mg, 10mg, 15mg and 20mg tablets, included nausea, constipation and vomiting. Like other antidepressants, Brintellix will have a boxed warning and a medication guide alerting that it can increase the risk of suicidal thoughts and behaviour in children, adolescents and young adults agesd 18 to 24 during initial treatment.
Brintellix iis an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. However, it is also 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. It is considered to be “the first and only compound with this combination of pharmacodynamic activity”, Lundbeck said, noting that it should be available to US patients by the end of the year.
Mitchell Mathis, acting director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said that “since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression”. Lundbeck R&D chief Anders Gersel Pedersen added that there are very few new antidepressants currently in development even though so many patients still struggle with the disorder so the firm is excited to be able to offer a new option.
