FDA Clears Prozac for Treatment of Bulimia.

INDIANAPOLIS--(HealthWire)--Nov. 25, 1996--Eli Lilly and Company announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Prozac(R) (fluoxetine hydrochloride) for the treatment of bulimia nervosa, an eating disorder that afflicts more than 1 million Americans each year. Prozac is the first medicine in the United States to be cleared for marketing by the FDA to treat this serious and potentially life-threatening medical condition.

This marks the third indication for Prozac, which already has been cleared by the FDA for use in the treatment of clinical depression and obsessive-compulsive disorder. Prozac was the first in a new class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) to be introduced in the United States.

"Prozac is the most time-proven medicine of its class and one of the most studied medications in the world," said Steven M. Paul, M.D., Lilly vice president of neuroscience research. "To the best of our knowledge, no other antidepressant has been more thoroughly tested in a clinical setting.

"As a company committed to scientific innovation and finding solutions for unmet medical needs," Paul continued, "Lilly is pleased to be able to offer patients in the United States the first proven drug therapy for the treatment of bulimia."

Bulimia is an illness characterized by recurrent episodes of uncontrolled binge-eating followed by some type of compensatory behavior, most often purging, which includes self-induced vomiting or misuse of laxatives and diuretics. The disorder strikes women almost exclusively. Nearly 3 percent of American women will suffer from the disorder during their lifetime.

Clinical studies have demonstrated that treatment with Prozac leads to a significant reduction in binge-eating and purging episodes, according to Freda C. Lewis-Hall, M.D., director of the Lilly Center for Women's Health. In eight-week clinical trials, women treated with 60 mg of Prozac daily experienced a 67 percent median decrease in binge-eating episodes and a 56 percent median decrease in vomiting episodes.

"Treatment with Prozac has been demonstrated to reduce the incidence of the destructive behaviors usually associated with bulimia," said Lewis-Hall, a psychiatrist. "An improved sense of control over binge-eating and purging behaviors is a crucial factor in the successful long-term management of this illness."

Other psychiatric illnesses, such as depression and obsessive-compulsive disorder (OCD), occur in more than half of patients with bulimia. And up to 50 percent of bulimia sufferers experience additional medical complications as a result of their illness, including fluid imbalances, dehydration and erratic heartbeat. In extreme circumstances, these complications can lead to cardiac arrest and, ultimately, death.

"Bulimia is an illness that, if left untreated, can result in devastating consequences," Lewis-Hall said. "Intervention and proper treatment are critical to helping patients resume a normal and healthy lifestyle. Prozac will provide physicians with a valuable new tool in the management of this illness."

Psychotherapy traditionally has been the primary treatment option for bulimia. Because of the complexity of the illness, Lewis-Hall said, the ideal treatment regimen for most patients likely will be a combination of medication and psychotherapy.

The most common side effects reported in the bulimia clinical trials included insomnia, nausea, asthenia and anxiety.

Prozac, the world's most widely prescribed branded antidepressant, was cleared for marketing in the United States for the treatment of clinical depression in 1987 and for OCD in 1994. It is estimated that more than 24 million people worldwide (more than 18 million people in the United States) have been treated with the medicine since its introduction. To date, Prozac has been made available for use in the treatment of depression in 107 countries and for OCD in 39 countries. The United States is the 34th country in which Prozac has received an indication for the treatment of bulimia.

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.

The company is committed to finding effective treatments for central-nervous-system disorders, with research and development efforts focusing on therapies for schizophrenia, Alzheimer's disease, depression, anxiety and pain. Lilly also maintains a commitment to women's health, with a portfolio of medications or investigational drugs targeted at diseases that disproportionately or exclusively afflict women, including breast, lung, ovarian, cervical and uterine cancer; eating disorders; urinary incontinence; and osteoporosis. -0- Prozac(R) (fluoxetine hydrochloride, Dista)

(Editors: Full prescribing information for Prozac(R) is available at no charge through Business Wire's News on Demand fax service. To obtain a copy, simply call 888-286-8107 toll-free and reference document number 4210.) -0-

Bulimia Nervosa: Medical Experts

Stuart Agras, M.D. Professor of Psychiatry Stanford University School of Medicine Stanford, Calif. [phone]

Katherine Halmi, M.D. Professor of Psychiatry Cornell University Medical College New York, N.Y. [phone]

David Herzog, M.D. Director Eating Disorders Unit Massachusetts General Hospital Boston, Mass. [phone]

James Hudson, M.D. Advisory Council American Anorexia/Bulimia Association Psychiatrist McLean Hospital Belmont, Mass. [phone]

Walter Kaye, M.D. Founder Academy for Eating Disorders Module Director of Eating Disorder Program University of Pittsburgh School of Medicine Pittsburgh, Pa. [phone]

Diane Mickley, M.D., F.A.C.P. President Emeritus American Anorexia/Bulimia Association Director Wilkins Center for Eating Disorders Greenwich, Conn. [phone]

Charles Murkofsky, M.D. President American Anorexia/Bulimia Association Medical Director Program for Managing Eating Disorders New York, N.Y. [phone]

Michael Strober, Ph.D. Director Eating Disorders Program Neuropsychiatric Institute UCLA Los Angeles, Calif. [phone]

Timothy Walsh, M.D. President Academy of Eating Disorders Professor of Clinical Psychiatry Columbia University New York, N.Y [phone]

For interviews with the following Eli Lilly and Company medical experts, please contact Victoria Murphy at [phone] or Greg Kueterman at [phone].

Steven Paul, M.D. Vice President of Neuroscience Research

Mark Demitrack, M.D. Clinical Research Physician

David Goldstein, M.D. Clinical Research Physician

Freda Lewis-Hall, M.D. Director Lilly Center for Women's Health

Steven Romano, M.D. Clinical Research Physician

CONTACT: Eli Lilly and Company, Indianapolis

Victoria L. Murphy, [phone]