FDA advisors remain skeptical about the safety of two antipsychotics for which regulatory approval is being sought and are especially troubled by potentially fatal cardiac risks.
Despite positive efficacy data from placebo-controlled trials, experts on a Food and Drug Administration (FDA) psychopharmacology advisory committee have reservations about potentially dangerous adverse effects of two antipsychotic medications under regulatory review for approval.
The FDA held meetings in April to seek the committee's advice on whether sertindole, a second-generation antipsychotic (SGA), should be approved for the treatment of schizophrenia and prevention of suicide in schizophrenia patients, and whether quetiapine XR extended-release tablets should be approved for treating major depressive disorder (MDD) as a monotherapy and as an adjunctive therapy to an antidepressant and for treating generalized anxiety disorder (GAD) as a monotherapy.
READ MORE @ PSYCHIATRIC TIMES
Showing posts with label sertindole. Show all posts
Showing posts with label sertindole. Show all posts
Saturday, May 16, 2009
Wednesday, April 8, 2009
FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic
Investigational antipsychotic drug sertindole (Serdolect) is effective at treating schizophrenia, but it may lead to sudden cardiac death, according to an FDA review.
The agency released its review in advance of Tuesday's meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug's cardiovascular risk is an obstacle to FDA approval.
The advisory panel will also consider the sponsor's suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
Sertindole is already used in other countries to treat schizophrenia.
According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug's potential to prolong the heart's QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole.
Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta.
READ MORE @ MADPAGE TODAY
The agency released its review in advance of Tuesday's meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug's cardiovascular risk is an obstacle to FDA approval.
The advisory panel will also consider the sponsor's suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
Sertindole is already used in other countries to treat schizophrenia.
According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug's potential to prolong the heart's QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole.
Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta.
READ MORE @ MADPAGE TODAY
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