LUVOX (Fluvoxamine Maleate) Tablets Offers Hope For Obsessive Compulsive Disorder (OCD) in Children And Adolescents

First SSRI to Gain Indication

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MARIETTA, Ga., March 25, 1997 -- LUVOX(R) (fluvoxamine maleate) Tablets is the first SSRI to gain clearance from the U.S. Food and Drug Administration (FDA) to treat Obsessive Compulsive Disorder (OCD) in children and adolescents. As the first selective serotonin reuptake inhibitor (SSRI) for this indication, LUVOX Tablets offers new hope for the estimated one million children and adolescents who have OCD. The product is jointly marketed by Solvay Pharmaceuticals, Inc. and Pharmacia & Upjohn, Inc.

OCD can strike in children as young as three or four, but is often undetected at this early age. Although children and adults experience many of the same obsessions (fear of contamination, need for symmetry, excessive doubt) and compulsions (excessive cleaning/washing, arranging/organizing, checking/questioning), children and adolescents with OCD are more likely to involve family members in their rituals. For example, they may insist their laundry be washed several times, demand that parents check their homework repeatedly, or become upset if siblings "contaminate" their bedroom.

Child and adolescent psychiatrist and OCD specialist, Mark Riddle, M.D., Director, Division of Child and Adolescent Psychiatry, Johns Hopkins Children's Center, considers the FDA clearance an important step in treating biological brain disorders in juveniles. "Until now, there has been little information about how children and adolescents react to various medications, while the need to medically treat this and other debilitating mental illnesses, is acute in this age category," said Dr. Riddle. "The clinical studies required for FDA review of fluvoxamine for children and adolescents have provided important information about the safety and efficacy of this medication in children."

LUVOX Tablets has been widely used for adults with OCD and has become the number one prescribed medication for OCD by psychiatrists in the United States.

Benefits of LUVOX Tablets

A 10-week, randomized, double-blind, placebo-controlled, multi-center study of LUVOX Tablets involving 120 children ranging in age from 8 to 17 years showed that fluvoxamine is more effective than placebo for the treatment of OCD. LUVOX Tablets was also well-tolerated; only three children taking fluvoxamine dropped out of the study due to adverse effects, none of which were considered serious. Most commonly observed side effects included agitation, hyperkinesia, depression, dysmenorrhea, flatulence and rash.

Conducting clinical tests and obtaining FDA clearance to market LUVOX Tablets for use in juveniles with OCD is only part of the process in helping these children. Experts agree that education is the key to helping children and adolescents with OCD gain appropriate medical treatment.

"It is critical we remove the stigma of the disease and its treatment so children and adolescents suffering from OCD can benefit from early diagnosis and treatment, and lead more fulfilling lives," said Larry Stone, M.D. president, American Academy of Child & Adolescent Psychiatry. "Many children with OCD benefit from a variety of treatments, including medication."

What Causes OCD?

Research suggests that OCD is caused by an imbalance of the brain chemical called serotonin. This imbalance can be genetic, even though the disorder itself may not be hereditary. People with OCD experience unwanted, recurrent and disturbing thoughts they are powerless to suppress. This causes overwhelming anxiety, prompting them to perform repetitive, ritualized, compulsive behavior to alleviate the anxiety.

Why OCD is Hard to Recognize

According to the National Institutes of Health, childhood OCD is more prevalent than other childhood ailments such as juvenile diabetes (100,000 cases in children 19 and under), yet remains largely undiagnosed and untreated. In young children, the disorder is often unrecognized because parents may attribute obsessive-compulsive behavior to a developmental stage and youngsters may not realize their thoughts and actions are unusual. Older children may hide their behavior, fearing that they are going crazy. Keeping this secret is exhausting and typically undermines a child's ability to function normally in school and at home. Relationships with family and friends deteriorate, and parents agonize over their child's peculiar behavior and hope "the phase" will pass quickly.

Impact of Untreated OCD

Children with OCD experience physical exhaustion and mental anguish from compulsive rituals such as repeated checking of school assignments, and obsessive fears such as harm coming to a family member as a result of household items being in disarray. Juvenile OCD can be particularly devastating because it coincides with a crucial period of social and emotional development. Schoolwork, home life and friendships are often affected.

LUVOX Tablets was developed in the U.S. by Solvay Pharmaceuticals, Inc. Solvay Pharmaceuticals and Pharmacia & Upjohn, Inc. formed a strategic alliance in May 1991 to jointly market LUVOX Tablets in the United States.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is a research-based pharmaceutical company active in the therapeutic areas of mental health, women's health and gastroenterology. It is a member of the Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.

Pharmacia & Upjohn, Inc., is a research-based pharmaceutically focused company dedicated to helping people around the world live longer and fuller lives. The company was formed through a merger of Pharmacia AB and The Upjohn Company and began operating in November 1995. Pharmacia & Upjohn, Inc. is a provider of human health care and related products, and operates on a global basis. The company has a corporate management center in London and major research and manufacturing centers in the United States, Sweden and Italy.

NOTE: For more information about Obsessive Compulsive Disorder (OCD)* call 1-800-NEWS-4-OCD (800-639-7462) or visit "The OCD Resource Center" on the Internet at http://www.ocdresource.com.

* The 800 number and OCD Resource Center Website are provided as a service from Solvay Pharmaceuticals, Inc. and Pharmacia & Upjohn, Inc.

CONTACT: Jill Dash, 212-448-4306, or Colleen Murphy, 212-448-4299, of Ketchum Public Relations; or Karen Kaplan of
Solvay Pharmaceuticals, Inc., 770-578-5637