The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) flashed partial green lights to 2 manufacturers of atypical antipsychotics. The committee recommended approval for 2 new uses for Seroquel XR (quetiapine fumarate) extended-release tablets and also gave first-time approval in this country for Serdolect (sertindole).
The latter recommendation, by a vote of 8 to 2 with 3 abstentions, may have been the more significant action. Drugs currently approved for schizophrenia do not mitigate all symptoms. However, the PDAC backed Serdolect for use only in narrow, still- to-be-determined schizophrenia populations and opposed a claim related to treatment of suicidal behavior in schizophrenia. The original application for Serdolect was filed in the United States in 1995 but was pulled 3 years later amid concerns that it might cause heart problems. Sales in Europe were suspended in 1999 but resumed in 2006 after additional studies reassured regulators about the safety of Serdolect. FDA reviewers told the panel they remained concerned about cases of sudden cardiac death in a study by Lundbeck and colleagues of about 10,000 patients who were given either Serdolect or risperidone(Drug information on risperidone). That accounted for the PDAC’s recommendation that the FDA approve the drug only for certain patients— categories the agency will ostensibly determine.
The PDAC’s action on Seroquel XR was also a mixed bag. The PDAC agreed that the drug was shown to be effective in major depressive disorder (MDD) as both monotherapy and adjunctive therapy, and that it was shown to be effective in generalized anxiety disorder as monotherapy. However, the panel said Seroquel XR was only safe as adjunctive therapy for MDD. Seroquel was approved in the United States in 2007 for the acute and maintenance treatment of schizophrenia in adults.
Wayne Goodman, MD, a member of the PDAC, told Psychiatric Times, “The important message of day 2 was the recommendation against broad approval of Seroquel monotherapy—not the approval for use as an adjunct.” Goodman is director of the division of adult translational research at the NIMH.