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FDA Approves Prozac Weekly (Fluoxetine) For Long-Term Depression Treatment

INDIANAPOLIS, IN -- February 28, 2001 -- Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) approved ProzacŪ Weekly™ (fluoxetine hydrochloride) for the continuation treatment phase of major depressive disorder.

Prozac Weekly is the first and only prescription medication administered weekly specifically for the continuation phase of long-term depression treatment. It is indicated for patients whose depressive symptoms have stabilized and who require continuing treatment to prevent a relapse, or return of symptoms.

"Depression can be a recurrent, chronic or long-term illness for most people who suffer from it," said Noel Gardner, M.D., associate clinical professor of psychiatry at the University of Utah and chief of consultation psychiatry, LDS Hospital, Salt Lake City. "A serious misconception about depression treatment is that as soon as symptoms go away, the patient is cured. In fact, a high percentage of patients who stop taking their medication too soon after symptom remission may experience a relapse within two months."

"Long-term treatment, even after symptoms remit, is vital to preventing relapse and the horrible despair that a return of symptoms can bring to a patient," said Dr. Gardner.

Prozac Weekly offers a new dosing option for patients who are committed to long-term treatment to control their symptoms and maintain health, and who also desire weekly dosing convenience that is not available with any other antidepressant.

"Prozac Weekly brings an element of choice into the long-term treatment paradigm," said Lilly's Gary D. Tollefson, M.D., Ph.D., distinguished Lilly research scholar and vice president, Lilly Research Laboratories. "This formulation is a safe and effective alternative for patients whose acute symptoms have stabilized. We believe Prozac Weekly may help patients maintain their wellness while reducing the chance they will relapse."

Prozac Weekly contains 90 mg of fluoxetine with an enteric coating that delays release into the bloodstream. This innovative formulation takes advantage of the protective effects provided by fluoxetine's naturally long half-life, allowing Prozac Weekly to be administered just once a week. In a clinical study, Prozac Weekly demonstrated significantly superior efficacy to placebo.
Prozac Weekly, in wallet-size packaging containing a four-week supply, will be available in pharmacies in early March 2001.

Clinical depression is one of the most common illnesses facing Americans. Yet many patients and health care providers don't know that depression requires long-term treatment to stay well.

Treatment guidelines issued by the Agency for Healthcare Research and Quality recommend that individuals whose depression symptoms have been controlled by medication should continue medical treatment for as long as nine months or more after symptoms remit. Otherwise, they face an increased risk of relapse, or a return of depressive symptoms.

In clinical trials, researchers examined 501 depressed patients who responded well to 13 weeks of therapy with fluoxetine 20 mg and who were then randomly assigned to treatment either with a 90 mg enteric-coated formulation of fluoxetine taken once weekly, fluoxetine at 20 mg daily or placebo for a 25-week, double-blind period.

Rates of relapse for patients treated either with the enteric coated or 20 mg formulation of fluoxetine were significantly lower than for those treated with placebo (p=.007, p<.001). Additionally, patients treated with either 90 mg or 20 mg fluoxetine rated significantly better on depression rating scales compared with patients assigned to placebo.

The most commonly observed adverse events associated with the use of fluoxetine (vs. placebo) in US controlled clinical trials for depression, OCD, and bulimia combined were: nausea (23 vs. 10 percent); headache (21 vs. 20 percent); insomnia (20 vs. 11 percent); anxiety (13 vs. 8 percent); nervousness (13 vs. 9 percent); and somnolence (13 vs. 6 percent).

Fluoxetine is contraindicated until at least two weeks have passed since discontinuing an MAO inhibitor, and an MAO inhibitor is contraindicated for at least five weeks after discontinuation of fluoxetine. Thioridazine should not be administered with fluoxetine or within a minimum of five weeks after fluoxetine has been discontinued.

Discontinue immediately if rash or other possibly allergic phenomena appear for which an alternative etiology cannot be determined.

Prozac Weekly is indicated for the continuation treatment of depression only.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

Related Link: Eli Lilly and Company.

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