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| |  Risperdal Oral Formulation New Option for Millions of Patients TITUSVILLE, N.J., July 15, 1996 -- Janssen Pharmaceutica announced today that it has recently received marketing clearance from the U.S. Food and Drug Administration (FDA) for an oral solution formulation of Risperdal(R) (risperidone). It will be available to patients starting today. Risperdal is currently the number one prescribed antipsychotic by psychiatrists and the only serotonin-dopamine antagonist (SDA) available for use as a first-line option in the treatment of schizophrenia. It has experienced tremendous growth since its introduction in 1994; in the last several months alone (January to May 1996), Risperdal prescriptions increased 73% while prescriptions for all antipsychotics combined increased only 5%, according to the National Prescription Audit of the market research firm IMS America. Due to its ease of administration, Risperdal oral solution will provide treatment benefits to a wider range of patients, particularly the elderly, for whom liquid formulations are frequently prescribed, and for patients treated in an acute care setting. Schizophrenia is a chronic illness that requires life-long treatment with medication. Risperdal oral solution will be an effective treatment option for elderly people with schizophrenia. According to a February 1996 study conducted by Intersearch Market Research Corporation, 50 percent of health care professionals at long-term care and psychiatric facilities crush tablets to ease administration. Risperdal oral solution eliminates the need for tablet crushing and provides a convenient treatment option for both acute patients and the elderly, who often have difficulty swallowing pills. Risperdal oral solution will also allow for more flexible dosing and contribute to increased treatment compliance. Treatment non-compliance is directly linked to relapse. Risperdal oral solution can be mixed with a variety of liquids to facilitate better compliance. "The tablet formulation of Risperdal has benefited more than one million Americans living with mental illness," said Paulo Costa, president, Janssen Pharmaceutica. "Oral Risperdal solution will allow us to improve even more lives by meeting the needs of people who are unable to take the tablet form." "Because patients with schizophrenia respond differently to medications, it is important that we have many treatment options," said Sanford Finkel, M.D., immediate past president of the International Psychogeriatric Association. "In the elderly, for example, ease of administration and flexibility in dosing are important considerations, leading to improved treatment. Risperdal oral solution will be a significant addition." Risperdal is indicated for the management of the manifestations of psychotic disorders, including both the positive symptoms (delusions, hallucinations and hearing voices) and negative symptoms (diminished emotional expressions) of schizophrenia, schizoaffective disorder and the psychotic features associated with bipolar disorder. Available in tablet form since 1994, Risperdal has an established safety and efficacy profile based on its success in treating over one million patients in the U.S. Clinical studies have shown that the incidence of extrapyramidal symptoms (EPS) with Risperdal, while dose dependent, is comparable to placebo at recommended doses. The most common side effects reported in clinical trials were insomnia, agitation, EPS, headache, anxiety and rhinitis; less common were somnolence, dizziness, constipation, nausea and tachycardia. Risperdal may also cause orthostatic hypotension, a form of low blood pressure, especially during the initial dosing period. Janssen continues to pursue advances for the treatment of illnesses associated with central nervous system disorders (CNS). As part of Janssen's commitment to CNS, Janssen is currently investigating treatments in the areas of Alzheimer's disease, stroke, anxiety and depression. Janssen Pharmaceutica has companies in 38 countries. U.S. headquarters are in Titusville, New Jersey.
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