FDA begins deliberations on Seroquel XR

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Sometime in the next several weeks, the FDA is expected to announce its decision on whether to approve the marketing of the atypical antipsychotic medication Seroquel XR for the treatment of depression and generalized anxiety disorder. The agency is weighing the safety and effectiveness of the drug both as a first-line therapy for these disorders and as treatment for those illnesses only after a patient has failed to get relief from antidepressant medication.

The agency got an earful last week from the advisory board on psychopharmacological drugs, which handed it a mixed bag of recommendations: the panel recommended against approval of Seroquel XR as a first-line treatment but with some reservations, advised that it should be approved as a treatment after others have failed.

Some of the issues raised in FDA’s deliberations are the subject of a package of articles running Monday in the LA Times’ Health section.

For AstraZeneca, the company that makes and markets Seroquel XR in the United States, an FDA approval could open a huge new patient population to its advertising and promotional messages. The company presented the results of trials it had conducted in support of its petition for FDA approval of the new indications.

But taxpayers have a stake in the decision as well. Seroquel is one of six drugs collectively called the atypical antipsychotics, because they work differently from the old generation of psychiatric medications, and the use of all of the drugs in the class has been exploding in the past decade or so--most of it for conditions for which FDA has not approved them. By one researcher’s estimate, 70% of those prescriptions were paid for by taxpayer-funded programs such as Medicare, Medicaid and the Veterans Administration.

The bill’s not cheap either: the Pharmacy benefits manager Express Scripts estimates that the average prescription for these drugs--marketed with names like Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa--is $270 per month. The average cost of the older class of antipsychotic drugs is about $18 of that. And antidepressants, many of which have gone generic, are averaging about $90.

--Melissa Healy