FOR IMMEDIATE RELEASE
CONTACT: Rachel Bloom, Zeneca Pharmaceuticals
302-886-7858
[email protected]
NEW DATA SHOW SEROQUEL(R) (quetiapine fumarate) TABLETS TREAT POSITIVE AND NEGATIVE SYMPTOMS OF SCHIZOPHRENIA WITH FAVORABLE SAFETY AND TOLERABILITY PROFILE
Wilmington, Del., - February 18, 1998 - Recent scientific data show that SEROQUEL(R) (quetiapine fumarate) tablets, the latest entrant for the treatment of schizophrenia, offer patients a new treatment option that not only addresses both the positive and negative symptoms of the disease, but does so with few of the traditional side effects of conventional or other atypical antipsychotic medications. Schizophrenia, a disease which is among the most complex of the psychotic disorders, affects nearly three million Americans, generally appearing between the ages of 15 to 30.
Data presented at a recent U.S. psychiatry conference (1) show several common concerns with antipsychotic therapy, and these are addressed very effectively by SEROQUEL: (a) abruptly switching from conventional therapies, such as haloperidol,(2) (b) reducing positive symptoms of schizophrenia without exacerbating negative symptoms,(3) (c) the potential for increasing compliance by minimizing side effects,(4) and (d) reducing aggression and hostility associated with schizophrenia without creating Parkinsonian-like symptoms.(5) Results from a multicenter, multiple-dose trial show that patients with psychoses can be switched safely to quetiapine from standard antipsychotic therapies and that quetiapine therapy can be discontinued safely when necessary.(1) "We have seen the life-changing benefits of SEROQUEL in the treatment of patients with schizophrenia," said Steven G. Potkin, M.D., Director of Clinical Psychiatric Research at the UCI Medical Center, Department of Psychiatry and Human Behavior in Orange, Calif. "In many patients, switching from conventional therapies to new medication can expose them to uncomfortable side effects. We have not found this to be the case when switching to SEROQUEL."
Another issue in schizophrenia treatment with conventional therapy is the clinical need to reduce positive symptoms (delusions, hallucinations, disorganized speech) without exacerbating negative symptoms (flattened emotional expression, apathy) or inducing Parkinsonian-like symptoms. In treating patients with psychoses, some antipsychotic therapies do not provide patients with full relief of symptoms. Due to the ability of SEROQUEL tablets to treat both positive and negative symptoms, patients often experience full relief of symptoms with few side effects.
A Reduction in Sexual Side Effects and in Hostility and Aggression Many patients with schizophrenia are noncompliant with their medication due to hormonal and reproductive side effects (impotence, enlargement of male breasts, abnormal secretion of breast milk, and menstrual irregularities), as a result of high prolactin levels, caused by many antipsychotics. Results from multicenter, double-blind, randomized, placebo-controlled trials have shown a very low incidence of reproductive system/hormonal side effects in patients treated with SEROQUEL and no statistical differences from placebo in plasma prolactin concentrations. Therefore, therapy with SEROQUEL may improve compliance and, ultimately, clinical outcome, unlike treatment with conventional antipsychotics. In addition, although standard antipsychotics can reduce aggression and hostility in acutely psychotic patients, they also can worsen negative symptoms or induce extrapyramidal symptoms (EPS) such as rigidity, shaking, and difficulty starting and stopping movement. A multicenter, double-blind, randomized, placebo-controlled trial demonstrated that SEROQUEL was superior to placebo in reducing positive symptoms and on all three measures of aggression and hostility in patients with acute exacerbation of schizophrenia--without producing EPS.4
Additional Background SEROQUEL is an atypical antipsychotic medication indicated for the management of the manifestations of psychotic disorders, including schizophrenia. In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. A maximum therapeutic effect was seen at 300 mg/day in a fixed dosing trial. A dosing regimen of two to three times daily is recommended. The drug is manufactured in the United States by Zeneca Pharmaceuticals and is available by prescription in strengths of 25-mg, 100-mg, and 200-mg tablets.
The efficacy of SEROQUEL, as well as the "atypical" profile which distinguishes the compound from standard antipsychotic agents, is supported by three placebo- and comparator-controlled Phase II and III clinical trials in patients hospitalized for acute exacerbation of chronic or subchronic schizophrenia. SEROQUEL was shown to be effective in treating both the positive and negative symptoms associated with schizophrenia. SEROQUEL was well tolerated in more than 4,000 male and female patients 18 years and older. The incidence of EPS with SEROQUEL was not different from placebo across the clinical dose range. Studies also demonstrated that SEROQUEL exhibits a low incidence of anticholinergic side effects (ie, dry mouth, constipation) and no significant prolongation of QTc intervals which may cause cardiac arrhythmias. No blood monitoring is required. As with other agents in its class, the labeling for SEROQUEL includes a warning relative to a rare condition known as tardive dyskinesia (which is often associated with long term use of antipsychotic agents) and neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Precautions include orthostatic hypotension (which may result in dizziness) and tachycardia (fast heartbeat). As with other antipsychotics, SEROQUEL should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. The most common adverse events exhibited across placebo-controlled trials included somnolence (18%), headache (19%), and dizziness (10%), and the majority of events rated as mild or moderate. The safety and effectiveness of SEROQUEL in pediatric patients (less than 18 years of age) have not been established. Zeneca Pharmaceuticals is a business unit of Zeneca Inc., a $3.1 billion bioscience business with approximately 7,200 employees in the United States. Zeneca Inc. is a wholly-owned subsidiary of the U.K.-based Zeneca Group PLC (NYSE:ZEN), a major $9 billion international bioscience business engaged in the research, development, manufacturing, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services.
(1)Association policy does not allow use of its name in media materials. Please contact Rachel Bloom of Zeneca Pharmaceuticals at (302) 886-7858 or [email protected] for more information and copies of the full abstracts. (2) Thyrum P., Yeh C., Potkin S., Maguire G., Bera R., Carreon D., Arvantis L. Safety and tolerability of switching from conventional antipsychotic therapy to 'SEROQUEL' (quetiapine fumarate) followed by abrupt withdrawal from 'SEROQUEL'. Poster presentation at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, Hawaii, December 1997. (3) Arvantis L., Miller B., Kowalcyk B. Efficacy of 'SEROQUEL' (quetiapine fumarate) in affective symptoms of schizophrenia. Poster presentation at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, Hawaii, December 1997. (4) Goldstein J., Arvantis L., Cantillon M. Low incidence of reproductive/hormonal side effects with 'SEROQUEL' (quetiapine fumarate) is supported by its lack of elevation of plasma prolactin concentrations. Poster presentation at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, Hawaii, December 1997. (5) Cantillon M., Arvantis L., Miller B., Kowalcyk B. 'SEROQUEL' (quetiapine fumarate) reduces hostility and aggression in patients with acute schizophrenia. Poster presentation at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, Hawaii, December 1997.
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