Lilly Files New Drug Application for Once-Weekly Formulation of Fluoxetine Hydrochloride

March 15, 2000       

INDIANAPOLIS, March 14 /PRNewswire/ via NewsEdge Corporation -

Eli Lilly and Company (NYSE: LLY) filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for a unique once-weekly formulation of Prozac(R) (fluoxetine hydrochloride) for the treatment of depression.

If approved by the FDA, Prozac will be the first and only antidepressant available in a once-weekly formulation.

"Prozac broke ground as the first SSRI (selective serotonin reuptake inhibitor) in the U.S. marketplace more than 10 years ago and is now poised to be the only antidepressant with this unique once-weekly formulation," said Gary Tollefson, M.D., Ph.D., president, Lilly neuroscience products, Eli Lilly and Company. "This innovation provides for a new paradigm in the treatment of depression and is an important choice for patients who have successfully completed acute treatment for depression and want an alternative for longer term therapy."

Prozac was introduced to the U.S. marketplace for the treatment of depression in 1988 and has since been approved in the United States for the treatment of obsessive-compulsive disorder and bulimia. Most recently, Prozac became the first antidepressant indicated for the treatment of depression in elderly patients.

Nearly 20 million Americans suffer from depression -- an often debilitating but treatable illness. Depression is, for many, a recurrent disorder. According to the Agency for Health Care Policy and Research, patients who suffer one major depressive episode have a 50 percent chance of a subsequent episode; patients who suffer from two major depressive episodes have a 70 percent chance of a subsequent episode.

Additionally, discontinuation of treatment following a response to acute-phase medication is followed by a 25 percent relapse rate within two months. For this reason, the Agency for Health Care Policy and Research recommends that patients receive up to nine months of continuation therapy after remission of depression symptoms to prevent a relapse in symptoms.

The most commonly observed adverse events associated with the use of Prozac vs. placebo in U.S.-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).

Prozac 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 with Prozac.

Prozac should be discontinued immediately if rash or other possibly allergic phenomena appear for which an alternative etiology cannot be identified.

Safety and effectiveness in pediatric patients have not been established.

Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering innovative pharmaceutical-based health care solutions that enable people to live longer, healthier and more active lives. Full prescribing information for fluoxetine hydrochloride is available by calling 800-545-5979 or at

SOURCE Eli Lilly and Company

CONTACT: Laura Miller, 317-277-1172, or Jeffrey Newton, 317-276-3570, both of Eli Lilly and Company

Company News On-Call: or fax, 800-758-5804, ext. 126236

Web site: (LLY)


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