Acadia issues states affirming positive risk profile of NUPLAZID
ACADIA Pharmaceuticals announced that the FDA has completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of NUPLAZID for patients with Parkinson's disease psychosis. NUPLAZID is the only medicine approved in the United States to treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP). NUPLAZID was approved by the FDA based on a pivotal Phase 3 study that demonstrated clinically robust and highly statistically significant efficacy, combined with other supportive studies. In assessing the reports of deaths, FDA considered that patients with Parkinson's disease psychosis, for whom NUPLAZID is indicated, have a higher mortality (death) rate due to their older age, advanced Parkinson's disease, and other medical conditions. Moreover, NUPLAZID is primarily distributed through a patient support program and a specialty pharmacy network, which increases the likelihood that deaths will be reported to the manufacturer. In FAERS reports that included a cause of death (many reports did not provide sufficient information to assess drug cause and effect), there was no evident pattern to suggest a drug effect. Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of NUPLAZID for Parkinson's disease psychosis. Although FDA did not identify any new or unexpected safety risks, some potentially concerning prescribing patterns were observed, such as the concomitant use of other antipsychotic drugs or drugs that can cause QT prolongation, a potential cause of heart rhythm disorder. The risk of QT prolongation and serious arrhythmia (abnormal heart rhythm) associated with NUPLAZID is noted in the Warnings and Precautions section of the drug label, which warns of the increased risks associated with using NUPLAZID together with other drugs known to cause QT interval prolongation. Based on this observation, FDA reminds health care providers to be aware of the risks described in the prescribing information. FDA also reminds heath care providers that none of the other antipsychotic medications are approved for the treatment of Parkinson's disease psychosis. Patients taking NUPLAZID for Parkinson's disease psychosis should continue to use it as prescribed by their health care provider. FDA continues to monitor reports of adverse events associated with NUPLAZID. The agency will communicate any updates to the public as necessary. To help FDA assess potential medication safety issues, we urge health care providers and patients to report suspected side effects involving NUPLAZID and other drugs to the FDA MedWatch program.