Helping to extend Seroquel’s existing reach, AstraZeneca, its maker, has received U.S. Food and Drug Administration (FDA) approval to market it as an effective treatment not only for mania associated with bipolar disorder, but also now for depressive episodes in bipolar disorder too. According to the Reuters report on the news:
The green light from the Food and Drug Administration makes Seroquel XR the first medication cleared in the United States for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.
Seroquel was first approved for the treatment of schizophrenia in 1997 by the FDA, and for manic episodes of bipolar disorder in 2004. The government-funded CATIE trials demonstrated mixed efficacy for Seroquel. Such research has called into question the effectiveness of such atypical antipsychotic medications versus both placebo and cheaper antipsychotics.
I haven’t had time to look at the research that backs this extended use of Seroquel (the generic name is quetiapine fumarate), but if the FDA approved it, they at least had some data to back this extended use. Given that Seroquel is AstraZeneca’s second biggest drug, the company will go to great lengths to ensure it continues producing big revenues for the company. Extending its approved uses goes a long way to help ensure Seroquel’s continued market dominance.
If you’re taking Seroquel, what this additional approval means is that your doctor may very well keep you on the medication longer-term, no matter what type of episode (manic or depressive) that you may be experiencing. This may make issues like keeping track of one’s medication a little bit simpler.
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5 Comments to
“Seroquel XR Gets Additional Approvals”
Just to clarify, as it was brought to my attention, that Seroquel XR is approved for use as an adjunct treatment for bipolar disorder. Specifically, it has been approved for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. Sorry if the above entry was confusing in that notation.
next on their list is approval for anxiety. After all, one cannot be anxious if one is so sedated to even think, much less ruminate with issues.
It borders on criminal what the antipsychotics are being marketed for these days, when, in my opinion as a psychiatrist, 5 to 15 dollars a pill is great incentive to get as many approvals as possible.
Does anyone know that Lilly was looking to get Zyprexa approved for migraine management about 3-4 years ago? Enough said!
therapyfirst (board cert psychiatrist)
Five bucks says that the patent was about up on Seroquel. AZ has to “reformulate” it, in order to reap the profits.
I take 200mgs at night and I used to also take 100mgs in the a.m. I’m not sure that an extended pill will help me. In fact, I wonder if I’ll have even more trouble getting up in the morning!
I take seroquel - my psychiatrist says I have ADD, PDDNOS, Anxiety Disorder and PDTS. He prescribes Seroquel to help me sleep - i just take one tablet at night - or two if I am having a bad run. If I take the pill I sleep, if I miss even one day I am lucky to get 3-4 hours sleep - if I don’t sleep I can get incredibly anxious and hypervigilant - and feel like there is broken glass all around me. I have never been diagnosed with the conditions it says the drug is approved for. Is that odd? have others been prescribed this drug when they don’t have the ‘approved’ conditions?
Robyn, I also take Seroquel (25 mg) as a sleeping aid. Nothing else seems to work for me, even Ambien causes me to jolt awake all night. I was originally prescribed it for stress hallucinations, it didn’t really help with that but that was when I found it helped me sleep. My current doctor now prescribes it to me only for sleep as I do not have any of the “on label” conditions.
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Last reviewed: By John M. Grohol, Psy.D. on 12 Oct 2008
