Brintellix ‘yes’ from FDA
pharmafile | October 4, 2013 | News story | Sales and Marketing | FDA, Lundbeck, Takeda, brintellix
Takeda Pharmaceutical Company and Lundbeck are celebrating after the FDA approved their depression treatment Brintellix – despite there being no clear idea of how it actually works.
Brintellix (vortioxetine) is indicated for adults with major depressive disorder (MDD), a mental illness which is estimated to affect 14 million people in the US, and the brand should be on the market by the end of the year.
The drug is an inhibitor of serotonin (5-HT) reuptake, 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 – although it is not known exactly how Brintellix creates its antidepressant effect.
So while it is believed to be the only compound with this combination of pharmacodynamic activity, the question of how – or even if – each element is relevant is unanswered at present.
What is not at issue the regulator believes, is that Brintellix works: six 6-8 week short-term studies – one on elderly patients that demonstrated statistically significant improvements in overall symptoms of depression – have proved its efficacy and safety.
Researchers used the mean change from baseline to endpoint in the Hamilton Depression Scale (HAMD-24) total score in two short-term studies, including the one on older people, and the Montgomery-Asberg Depression Rating Scale (MADRS) total score in the others.
There was also a 24-64 week maintenance study which saw Brintellix treatment increase the time to recurrence of depressive episodes (defined as a MADRS total score ≥ 22 or as judged by the investigator) compared to placebo.
Starting dose is 10mg once daily, but this should be upped to 20mg if tolerated, since higher doses demonstrated better outcomes in trials: the main adverse events in MDD patients treated with Brintellix were nausea, constipation and vomiting.
“MDD is a multifaceted disorder that encompasses emotional, physical and cognitive symptoms that may make it challenging to treat,” said Michael Thase, Professor of Psychiatry at the University of Pennsylvania’s Perelman School of Medicine.
“Because patients respond to treatments differently, it is important to have additional new options available to help address the overall symptoms of major depression,” he said.
Discovered by Lundbeck researchers in Copenhagen, the drug was taken through its US trial programme by both companies, and Takeda holds the licence for the country.
The World Health Organisation predicts that depression will become the leading cause of disability by the year 2030.
“There are very few new antidepressant drugs currently in development even though so many patients still struggle with depression,” said Anders Gersel Pedersen, head of R&D at Lundbeck.
Adam Hill
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