FDA Approves Seroquel (quetiapine fumarate) Tablets for
Treatment of Acute Mania Associated With Bipolar Disorder
Those Suffering From Mania Associated With Bipolar
Disorder Now Have a New Option
(Jan. 12, 2004) -- U.S. Food and Drug Administration (FDA) has approved
SEROQUEL as a monotherapy (alone) and adjunct therapy with
lithium or divalproex, for the short-term treatment of
acute manic
episodes associated with bipolar I disorder. The approval is based on
results of several registration trials for bipolar disorder, which showed
Seroquel to be well-tolerated and effective in the treatment of manic episodes
- excited mental states seen in bipolar disorder that are characterized by
impulsive behavior, racing thoughts, pressured speech, and decreased need for
sleep. Patients taking Seroquel in the registration trials, either as a
monotherapy or as an adjunct to divalproex or lithium, showed improvement of
their manic symptoms within the first week of treatment. The improvement was
statistically superior to that of placebo or placebo plus lithium or divalproex
as measured by the Young Mania Rating Scale (YMRS), a common psychiatric
measurement tool.
In the monotherapy studies, 77% of patients who responded to Seroquel (100
of 208) had achieved remission by day 21.(1) Response was defined as greater
than or equal to 50% decrease from baseline YMRS score and remission was
defined as YMRS score less than or equal to 12. Seroquel also has shown promise
in reducing the agitation, hostility and aggression sometimes associated with
manic episodes.(1,2) Further, these studies show that Seroquel works across a
broad range of mood symptoms as evidenced by improvement in key measures of
symptoms associated with bipolar
mania.(1,2) Seroquel also showed a favorable side-effect profile in
particular to extrapyramidal symptoms (EPS) and serum prolactin elevation
across the entire dose range.
"The new indication for Seroquel represents another treatment option
for the millions of people who suffer from bipolar mania," said Dr. Trisha
Suppes, Bipolar Disorder Research Program Director, University of Texas
Southwestern Medical Center. "While results for individual patients may
vary, Seroquel was well tolerated in clinical trials and represents a new
option for the treatment of acute mania associated with bipolar disorder."
Seroquel, which has been approved for the treatment of schizophrenia in
adults since 1997, is the fastest-growing leading psychotropic medication on
the market in the United States.**(3) Since its initial approval for
schizophrenia, there have been approximately 21.5 million prescriptions written
for Seroquel, for more than 5.3 million patients in the United States.(4)
Seroquel Clinical Trial Results
A pooled analysis of data from two double-blind, randomized, placebo-
controlled trials assessed the efficacy and safety of Seroquel monotherapy for
the treatment of acute manic episodes in a large cohort of adults with bipolar
I disorder. Seroquel was given in doses up to 800 mg/day. The primary endpoint
was changed from baseline YMRS (Young Mania Rating Scale) total score at day 21
of treatment.(1) Results showed that:
- After three weeks, 48.1% of Seroquel-treated patients achieved a response
versus 31.3% of the placebo group (p=0.001).
- After three weeks, 37.5% of Seroquel-treated patients achieved remission
versus 23.1% with placebo (p=0.002).
In a separate, double-blind, multicenter, randomized, placebo-controlled
trial, Seroquel, when administered as an adjunct to lithium or divalproex in
the treatment of acute manic episodes in 191 patients with bipolar disorder,
achieved a significantly greater response rate compared to lithium or
divalproex alone (54.3% vs. 32.6%, p=0.0005). The trial also found that the
Seroquel-treated group had significantly greater response compared to lithium
or divalproex alone (50.6% vs. 31.5%, p=0.012) as defined by extent of
improvement (much or very much improved) in the Clinical Global Improvement/BP
Score. Seroquel was well tolerated with an incidence of EPS no different from
placebo across the dose range.(2)
"The approval of Seroquel in the treatment of bipolar mania
demonstrates the commitment of AstraZeneca to providing medicines that help
patients with mental illness," said Dr. Jamie Mullen, Senior Director of
Clinical Research at AstraZeneca. "Seroquel is an excellent example of the
company's dedication to finding effective treatments that patients can
accept."
Seroquel has recently received approval from the Mutual Recognition
Procedure (MRP) involving 14 European countries to extend its use to treat
mania associated with bipolar disorder. Health authority approvals have also
been received in the UK, Italy, Mexico and New Zealand.
About Seroquel
The efficacy and tolerability profile of Seroquel is supported by several
placebo- and active-controlled clinical trials in patients with schizophrenia
and bipolar mania. In studies supporting the approval of Seroquel®
(quetiapine fumarate) Tablets, there were no differences from placebo across
the clinical dose range in the incidence of EPS, including rigidity and
difficulty starting and stopping movement, or in elevation of serum prolactin
levels.
In both adjunct and monotherapy bipolar mania clinical trials efficacy was
demonstrated in a dose range of 400mg/day to 800mg/day. In clinical trials
pertaining to schizophrenia, efficacy was demonstrated in a dose range of
150mg/day to 750mg/day.
Important Safety Information About Seroquel
Prescribing should be consistent with the need to minimize the risk of
tardive dyskinesia (which is often associated with long-term use of
antipsychotic agents), seizures, and orthostatic hypotension. A rare condition
known as neuroleptic malignant syndrome (NMS symptoms include muscle rigidity,
fever, and irregular pulse) has been reported with this class of medications,
including Seroquel. There have been reports of diabetes mellitus and
hyperglycemia-related adverse events associated with the use of atypical
antipsychotics, including Seroquel.
The most common adverse events associated with the use of Seroquel as
monotherapy for either schizophrenia or bipolar mania were somnolence (18%),
dizziness (11%), dry mouth (9%), constipation (8%), SGPT increase (5%),
dyspepsia (5%) and weight gain (5%). The most common adverse events associated
with the use of Seroquel as an adjunct therapy with lithium or divalproex in
bipolar mania were somnolence (34%), dry mouth (19%), constipation (10%),
asthenia (10%), abdominal pain (7%), postural hypotension (7%), pharyngitis
(6%), and weight gain (6%). When weight gain was defined as an increase in
weight of 7% or more from baseline, there was a statistically significant
incidence of weight gain in patients receiving Seroquel (23%) vs. patients
receiving Placebo (6%). The safety and effectiveness of Seroquel in pediatric
patients have not been established.
SOURCE: AstraZeneca press
release
References
- Jones MW, Huizar K, et al. Quetiapine monotherapy for acute mania
associated with bipolar disorder (STAMP 1 and STAMP 2) [poster]. Presented at
the American Psychiatric Assn meeting, San Francisco, Calif., May 20, 2003.
- Sachs G, Mullen JA, Devine NA, Sweitzer DE. Quetiapine versus placebo as
adjunct to mood stabilizer for the treatment of acute mania [abstract]. Bipolar
Disorders. 2002;4 (Suppl 1); 133.
- Based on 2002 versus 2001 TRx growth for the top three Atypical
Antipsychotic products, NPA Plus, IMS Health.
- Data on File
- Kluger K and Song S. Young and Bipolar. TIME, August 11, 2002
- Kramlinger, K. Mayo Clinic on Depression. Rochester, Minn.: Mayo Clinic
Health Information, 2001.
Related Information:
back to
top | home
|
