Symbyax, First Medication For Bipolar Depression Approved By
FDA
Symbyax Combines Active Ingredients Of Zyprexa And
Prozac To Fill Unmet Medical Need
(December 29, 2003) -- Symbyax, a drug that treats depression caused by bipolar
disorder, was approved by the U.S. Food and Drug Administration and
will hit pharmacy shelves by mid-January.
Symbyax is a combination of ingredients in two other Eli Lilly products:
olanzapine, the active ingredient in Zyprexa, and
fluoxetine, the active ingredient in Prozac.
About Symbyax For Bipolar Depression
About 2.5 million Americans have a diagnosis for bipolar disorder, which is
also called manic-depressive illness. Lilly adds that as many as 10
million Americans may actually be sufferers.
 Patients with bipolar disorder
spend more than three times longer in the depressive phase than in the manic
phase of the disorder and take longer to recover from it. Additionally, the
depressive phase of bipolar disorder is associated with higher rates of
morbidity and mortality, according to Dr. Terence Ketter, M.D., chief, Bipolar
Disorders Clinic, Stanford University. It is estimated that one in four people
with bipolar disorder will attempt suicide at least once, and the relative risk
of suicide among patients with bipolar depression has been shown to be nearly
35 times greater than for patients in the manic phase of bipolar disorder.
(
Dr. Terence Ketter talks about the
devastating impact of bipolar depression. Watch using your windows media
player.)
Symbyax treats the depressive episodes that stem from bipolar disorder. The
drug's effectiveness was demonstrated by an eight-week study published in
November in the Archives of General Psychiatry, according to an Eli
Lilly press release.
Rapid Onset for Symbyax
Although it can take up to 4 weeks or so to feel the full effects of
Symbyax, Rakesh Jain, M.D., M.P.H., a principal investigator for the Symbyax
clinical studies told HealthyPlace.com that the "onset can be very rapid,
within a week." Dr. Jain says that in his studies, some patients began to
experience symptom relief in less than a week.
Among the initial benefits, according to Dr. Jain, are improved sleep and a
significant reduction in irritibility and anxiety. After that, "the core
symptoms of depression begin to get better," says Jain.
Zyprexa/Prozac Combo
Zyprexa is a mood stabilizer used to treat the mania associated with bipolar
disorder. Prozac was the first SSRI developed for depression. But for many
bipolar patients, taking an SSRI can induce mania.
Dr. Jain tells HealthyPlace.com that Zyprexa manages the mania while the
Prozac deals with the depression symptoms. "Another thing many people may
not be aware of is that Zyprexa is a decent antidepressant," says Jain.
"It's not a great one, but it does have antidepressant properties."
Symbyax Side Effects and Duration of Treatment
People with bipolar depression suffer a high rate of relapse. "It has a
nasty habit of coming back," says Dr. Jain. "Relapse is the rule, not
the exception. So using Symbyax as maintainence therapy is the goal, even
though it hasn't yet been approved for that by the FDA," says Dr. Jain.
But what about long-term use? At this point, there are no clinical studies
dealing with extended use of Symbyax. According to Dr. Jain, one of the key
side effects of Symbyax is weight gain, associated principally with Zyprexa.
"At the onset of taking the medication," Dr. Jain tells
HealthyPlace.com, "the doctor and patient should be discussing changing to
a healthy diet and establishing an exercise program to deal with this
problem."
Possibly because of the weight gain aspect of Zyprexa, the antipsychotic
drug has been
linked to causing diabetes in some patients. Dr. Jain says
that although it's not an FDA requirement for Symbyax, patients, as a matter of
course, should have their blood sugars and lipids checked on a periodic basis.
The most common adverse event reported in patients taking Symbyax in
clinical trials was drowsiness. Other common events noticed in clinical trials
were weight gain, increased appetite, feeling weak, swelling, tremor, sore
throat, and difficulty concentrating.
Not Everyone is Enthusiastic
Some health care experts said the combination offers little advantage
because of the side effects associated with each drug alone.
"I don't intend to use it," said David Printz, director of the
Bipolar Disorder Research Clinic at New York State Psychiatric Institute, part
of Columbia University Medical Center. "Medications have been down this
road before and there's relatively little flexibility in the combination
produced."
Moreover, Printz said neither Prozac nor Zyprexa would be near the top of
his list for treating bipolar depression. Prozac stays in the body longer than
some other antidepressants in its class, raising the risk that the patient will
swing from depression to mania, he said.
The addition of Zyprexa is designed to offset that. But Printz said that of
all the drugs known as atypical antipsychotics, he would use Zyprexa last. He
said patients using it gain more weight than they do using rival drugs. Some
researchers believe the weight gain has led to diabetes among some patients.
Prudential Equity Group estimates Symbyax will add just $100 million to
total sales of the Zyprexa line of products in 2007, in part because Symbyax
prescriptions will lower the amount of Zyprexa prescriptions -- a phenomenon
called "cannibalizing" sales of the original product.
The first choices of treatment for most doctors in treating the depressive
phase of bipolar disorder are mood stabilizers such as Lithium or Abbott
Laboratories Inc.'s Depakote. One of the increasingly popular drugs being used
is GlaxoSmithKline Plc's Lamictal.
SOURCES: Eli Lilly press release,
Rakesh Jain, M.D., M.P.H., University of Texas Medical School.
More Symbyax Information
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