• In September 1997, Seroquel was cleared for marketing by the US Food and Drug Administration (FDA). Seroquel is an oral medication indicated for the management of the manifestations of psychotic disorders, including schizophrenia.

• Seroquel belongs to a new chemical class of atypical antipsychotics known as dibenzothiazepine derivatives.

• Three, short-term (six weeks or less) controlled trials of psychotic patients demonstrated that Seroquel is effective in treating both the positive and negative symptoms associated with schizophrenia.

Additionally, the incidence of extrapyramidal symptoms (EPS) with Seroquel was no different from placebo across the clinical dose range. Elevations in plasma prolactin levels among study participants in the Seroquel groups were no different from the placebo-treated groups across the clinical dose range.

• Studies showed Seroquel to exhibit a low incidence of anticholinergic side effects (i.e., dry mouth, constipation) and no blood monitoring is required.

• Seroquel is manufactured in the US and is currently available by prescription throughout the US in strengths of 25 mg, 100 mg, and 200 mg tablets.

In one clinical trial, 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 in two divided doses daily. In other studies, doses in the range of 400 – 400 mg/day were effective. A dosing regimen of two to three times daily is recommended.

• The labeling for Seroquel (like other agents in its class) includes a warning relative to a rare condition known as tardive dyskinesia, a condition often associated with long term use of antipsychotic agents, and neuroleptic malignant syndrome (NMS). Symptoms of NMS include muscle rigidity or irregular pulse.

• Label precautions for Seroquel include orthostatic hypotension (dizziness) and tachycardia (fast heartbeat). Also included is a precaution for seizures. 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 has not been established.

• Prior to the introduction of Seroquel, medications used to treat schizophrenia include older, first-generation, "typical" agents (haloperidol) and newer, atypical antipsychotics (clozapine, olanzapine, risperidone).

• Seroquel was discovered and developed by Zeneca Pharmaceuticals, a business unit of Zeneca Inc., in its US research laboratories in Wilmington, DE. Zeneca submitted a New Drug Application (NDA) with the FDA for Seroquel tablets on July 29, 1996.

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