SILVER SPRING, Md., April 7 -- An FDA advisory panel voted to recommend FDA approval for sertindole (Serdolect) to treat schizophrenia, but only for a subgroup of patients that the agency would have to define.
The lukewarm backing came in part because of studies showing that patients taking sertindole were more than four times as likely to die suddenly, compared with another atypical antipsychotic, risperidone (Risperdal).
In fact, the Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that the drug is not "acceptably safe" for the general schizophrenic population.
But the panel unanimously agreed the drug is effective and then voted 8 to 2, with three members abstaining, that some patients might benefit from having sertindole as an option.
The committee did not clearly identify those patients, however, leaving it to the FDA to decide which patients, if any, should receive the drug, manufactured by Lundbeck and currently marketed in other countries.
One panelist suggested that sertindole only be prescribed for schizophrenics who have not responded to other drugs, and another suggested performing cardiac tests to give some hint of whether a patient might be at increased risk for heart problems.
"I would hope this is a treatment of last resort," said Gail Griffith, M.S., the consumer representative on the panel.
Sertindole prolongs the heart's QT interval, which may lead to major cardiac problems, including sudden death. In the sponsor's trial, there were 13 sudden cardiac deaths among patients taking sertindole and three among patients taking risperidone (P=0.002).
"The cardiovascular risk is real, but I think that is counterbalanced by the need for other treatment," said Sheryl Kelsey, Ph.D., professor of epidemiology at University of Pittsburgh. Kelsey is a temporary member of the Cardiovascular and Renal Drugs Advisory Committee, which had three of its members voting on Tuesday's panel.
Sudden cardiac death has been seen in other antipsychotic drugs similar to sertindole.
(See: Risk of Sudden Death No Less Likely with Atypical Antipsychotics)
The panel also swatted away Lundbeck's proposed claim that sertindole could help prevent suicide among schizophrenic patients. About half of all schizophrenic patients attempt suicide, according to the drugmaker.
But the committee voted 12 to 1 that patients taking sertindole are no less likely to contemplate, attempt, or succeed in taking their lives, compared with those taking antischizophrenia drug risperidone.
An FDA analysis found that 36 sertindole-treated patients attempted suicide, compared with 54 in the risperidone group, but the difference failed to reach statistical significance.
The efficacy data on which the panel based its vote came from the sponsor's trials involving more than 10,000 patients.
These studies adequately proved the short-term antipsychotic efficacy of 12- to 20-mg daily doses of sertindole, according to the lead FDA staff reviewer, psychiatrist Phillip Kronstein, M.D.
The FDA does not have to follow the advice of its advisory panels, but it usually does.
(See: FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic)