EMBARGO FOR RELEASE MONDAY, JUNE 1, 1998, 9 a.m., EDT
After being institutionalized for more than 10 years, doctors worried that Claudette Jacobs Derk, who suffers from schizophrenia, would never gain control of her disease. However, after her doctor initiated therapy with SEROQUEL(R) (quetiapine fumarate) tablets, DerkÃs hallucinations, delusions, and most of the other symptoms associated with her illness disappeared. After just one week of taking SEROQUEL, Derk, 58, was finally able to spend a week at home with her family. This visit was so successful that Derk was able to be discharged from the hospital on a permanent basis.
Nearly three million Americans suffer from schizophrenia, a severe, chronic, brain disorder caused by a malfunction of the neurotransmitter controlóthe biochemical wiringóof the brain. This often debilitating illness is associated with hallucinations, delusions, apathy, and social withdrawal. SEROQUEL, a product of Wilmington-based Zeneca Pharmaceuticals, is an atypical antipsychotic indicated for the management of the manifestations of psychotic disorders, including schizophrenia.
Ralph Zaroff, DO, is a psychiatrist at Allentown State Hospital, Allentown, Penn., where he treated Ms. Derk. ìI was amazed at the transformation that Claudette underwent once I switched medications,î Zaroff said. ìIt was not until she was initiated on SEROQUEL that she improved. Within a week the change in her was incredible. She was more relaxed, yet not sedated, she was interested in her appearance, she stopped shaking, and she wanted to socialize. In addition, she did not experience any side effects.î
A common issue in the treatment of schizophrenia 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 (tremors, muscle stiffness, and muscle rigidity). In treating patients with psychoses, some antipsychotic therapies do not provide patients with full relief of symptoms. Because SEROQUEL has been shown to treat both positive and negative symptoms, patients like Derk often experience relief of symptoms with few side effects. In fact, SEROQUEL has been shown to effectively address several common treatment concerns while minimizing some of the troublesome side effects associated with traditional antipsychotic therapy, such as extrapyramidal symptoms and sexual/hormonal side effects.
ìI have suffered and struggled with my illness for many years,î commented Derk. ìI think SEROQUEL has given me back my dignity, my life, something to live for.î
Background on SEROQUEL(R) (quetiapine fumarate) Tablets
SEROQUEL is the latest entrant in the class of drugs known as atypical antipsychotics. In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. An initial target dose range of 300-400 mg can be given two times daily. 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 tablets, as well as the atypical profile, is supported by a total of 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 extrapyramidal symptoms (EPS) with SEROQUEL(R) (quetiapine fumarate) tablets 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 antipsychotics, the labeling for SEROQUEL tablets 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 s ymptoms 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 headache (19%), somnolence (18%), and dizziness (10%), with 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 $3.6 billion bioscience business with approximately 7,500 employees in the US and Canada. Zeneca Inc. (in the US) and Zeneca Corp. (in Canada) are both wholly-owned subsidiaries of the UK-based Zeneca Group PLC (NYSE:ZEN), a major $8.6 billion international bioscience business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of healthcare services.
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NOTE: For full prescribing information for SEROQUEL tablets, visit the US Zeneca Pharmaceuticals web site at www.usa.zeneca.com
Contact:
Rachel Bloom
Zeneca Pharmaceuticals
(302) 886-7858
[email protected]
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