May 18, 2007

Seroquel XR (Extended-Release) Approved for Schizophrenia

The U.S. Food and Drug Administration (FDA) has approved Seroquel (quetiapine fumarate) XR extended-release tablets for the treatment of schizophrenia. Seroquel XR is a product of AstraZeneca. The new extended-release formulation of Seroquel is intended as a once-daily medicine for the treatment of schizophrenia in adult patients.

The company says that the Seroquel XR development program was based on the needs of patients and physicians for a wider choice of medicines that offer convenient once-daily dosing. With Seroquel XR, patients can achieve a dose within the recommended range as early as the second day of treatment.

The FDA approval was based on clinical trial data showing effectiveness of Seroquel XR at doses of 400, 600, and 800 mg/day.

The clinical trial was a placebo-controlled study of inpatients and outpatients (n=573) experiencing an acute exacerbation of symptoms of schizophrenia. The US patent for Seroquel XR expires in 2017. Seroquel XR will be launched in the USA in the second half of 2007.

Lisa Schoenberg, Vice President, Specialty Care (Neuroscience, Oncology), AstraZeneca said,

"The once-daily dosing of Seroquel XR may help patients by providing simpler and more convenient treatment plans, which can be an important component of overall disease management."

The one negative aspect of these types of time-release medications that everyone should be aware of is that they typically lose their "time release" feature if the pill is broken in two (or more) pieces. So the practice of "pill-splitting" which is very common with schizophrenia medications (used to lower the cost of medications - because the higher dose meds are not priced proportional to the amount of medication in the pill). So - on the one hand these time-release medications are positive because they simplify people's medications schedules - but on the downside, they could result in a significantly more expensive medications cost because pill splitting is no longer feasible with the time-release meds.

Read the Full Press Release: FDA Approves AstraZeneca's Once-Daily SEROQUEL XR Extended-Release Tablets For The Treatment Of Schizophrenia

Related Reading:
FDA orders AstraZeneca to Modify Promotions on Seroquel
CATIE II - Schizophrenia Treatment Study Update
Treatment of Adolescent and Child Schizophrenia
CATIE Results - Perphenazine almost as good as newer drugs
Adjunctive Topiramate for Treatment Resistant Schizophrenia


dear sir madam
my friend has been taking seroquel for over 5 years and it has really helped his schizophernia thers not eny bad side effects of the drug at all he said .i asked him a couple of questions before e mailing u . the only thing he didnt like was when the first gave him them he said his heart rate would go up rapidly before the drug kicked in .but he is used to it know and it isnt a problem at all he said to me .

Posted by: scottlarock at May 23, 2007 06:09 AM

My son is taking this medicine@ 250 mg per day(125mg+125mg). Since half life is only 6 hrs the effect is considerably lost after 6 hrs. Therefore, I want him to use extended release tablets. I would like to know the price of extended release tablets of 250 mg.

Posted by: B Anjaneyulu at October 11, 2007 11:24 AM

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