FDA issues complete response letter for Brintellix sNDA
Posted: 29 March 2016 | | 1 comment
The FDA have issued a CRL to include new data in the clinical trials section of the US label of Brintellix for treating aspects of cognitive dysfunction in MDD…
Takeda and Lundbeck have announced that the US Food and Drug Administration (FDA) have issued a complete response letter (CRL) for the supplemental new drug application (sNDA) to include new data in the clinical trials section of the US label of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).
The FDA approved Brintellix in 2013 for the treatment of MDD in adults. The CRL does not apply to the use of Brintellix in MDD.
In a statement, Takeda and Lundbeck have said they are disappointed with the response given that the US FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that Takeda and Lundbeck presented substantial evidence to support a claim of effectiveness for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD. However, the companies were pleased that FDA recognised the importance of cognitive dysfunction in MDD and view it as a legitimate target for drug development.
Takeda and Lundbeck also said that they look forward to reviewing the contents of the letter with the FDA to determine the appropriate path forward.
Brintellix was discovered by Lundbeck researchers
The mechanism of the antidepressant effect of Brintellix is not fully understood. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. 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. The contribution of each of these activities to Brintellix’s antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is unknown.
The therapy was discovered by Lundbeck researchers in Copenhagen, Denmark. Takeda holds the new drug application for the US market.
Related organisations
Food and Drug Administration (FDA), H. Lundbeck A/S, Takeda Pharmaceutical Company Limited
There’s no antidepressant I haven’t tried in my 24 yrs of life. After giving every medicine a chance and struggling to see if it will work or help me get free from my clinic depression, I honestly lost hope and thought it all was a waste.
Two months ago my family doctor saw me and I saw a add about this nrand new antidepressant. I wasn’t hopeful but asked to try it thinking it could be either a miracle pill or just a 80th disappointment
Within 4 or 5 days, I was blown away. Finally they made a drug that works on every chemical in the brain. I had hope again and felt like “this is me, the best of me.” I’ll never take any other antidepressant. They should have worked on this way long ago. SsRIs are a joke compared to Trintellix.
Now, (I’m gonna cry writing this) my insurance company is refusing to pay for it. My doc put me up last week to the full 20mg, after taking 10mg for 2.5 months. I hung up the phone devastated, that isn’t even a word for how I felt, it broke my heart in pieces. I saw light finally with Trintellix and now I have faith in nothing. Everything good crashes, and a drug o found life changing taking it is over. I guess insurance doesn’t care , they say there s so many other options , what they obviously don’t comprehend is MOTHING HAS JELPED LIKE BRINTELLIX FOR TREATMENT RESISTANT DEPRESSION. Money is their goal, at the end of the day they couldn’t care less.
I just find it unbelievable how you find a light at the end tunnel, and it’s always a lost hope. Why did I even try it, wish I never had.
Faith what is faith? I’ve lost it and give up. Thanks insurance. I’ll be laying in bed now not wanting to move or do anything. Anything too good is too good yo ne true.money is why we all suffer when we find a cure for ourselves, NO OBE CARES. MONEY IS MORE PRECIOUS THAN PEOPLE’S DISORDERS AND LIVES.
Now all I want is to lay in bed and never get out. I’ll remember how different I felt, like a ne born baby, now I’m nothing again and even more depressed D. Thank you, insurance. Money is all and everything , not mental helpless ppl. I’m done, this writing doesn’t even matter… Goodnight, heartache.