Bipolar Disorder Drug Stavzor Gets Tentative Fda Approval
The U.S. Food and Drug Administration moved one step closer to providing individuals with bipolar disorder another option for drug treatment.
Recently, the FDA tentatively approved the drug Stavzor for treatment of the manic episodes associated with bipolar disorder, epilepsy and migraine headaches.
But don't expect to see it on the market just yet. "Tentative approval" means that the Food and Drug Administration finds that the drug meets all the necessary standards for quality, safety and effectiveness. But, there are still issues to be worked out regarding existing patents or exclusivity rights. For these reasons, the drug for bipolar disorder cannot yet be marketed in the United States.
The company manufacturing Stavzor, Noven Pharmaceuticals, Inc., says that the exclusivity issues involve the drug Depakote, made by Abbott Laboratories. This drug also treats manic episodes associated with bipolar disorder, epilepsy and migraines. Both products include valproic acid as a key ingredient. Depakote's exclusive hold on the market is due to expire shortly.
If Stavzor is approved for marketing for bipolar disorder, it would then become a branded rival of - not a generic substitute for - Depakote. Officials at Noven said that they are hopeful that the drug will be approved by the end of July 2008.
Stavzor is a delayed release drug for the treatment of bipolar disorder. It will be available in 125 mg, 250 mg and 500 mg strengths.
Bipolar disorder is a mental illness which is characterized by extreme mood swings from severe depression to a manic euphoria. The depressive episodes can be so severe at times that individuals may attempt suicide.
The manic episodes associated with bipolar disorder can be characterized by an inappropriate sense of self-confidence, even a feeling of invincibility and a sense of grandeur, racing thoughts, rapid speech and spending several days in a row without sleep. Most often diagnosed when an individual is in his late teens or early 20s, bipolar disorder diagnoses are increasingly being made on younger children as well. This is due in part to an expanding definition of bipolar disorder.
