FDA Drug Review News
Advisory Panel to the U.S. Food and Drug Administration (FDA) Reviews Drug for Parkinson’s Related Psychosis
An advisory panel to the U.S. FDA voted 12 to 2 that the benefits of pimavanserin (Nuplazid®) outweigh the risks for patients with psychosis associated with Parkinson’s disease. However, the advisory panel did not vote on whether to recommend the drug for approval. Concerns remain regarding the safety of the medication, and it has been suggested, if approved, the indication of the drug needs to be very specific to reduce off-label use.
Parkinson’s disease psychosis (PDP) is estimated to affect about 40% of patients with Parkinson’s disease and is characterized by visual hallucinations and delusions. There are currently no FDA-approved drugs for the treatment of PDP, and the condition is associated with significant caregiver distress as well as increased patient morbidity and mortality. Antipsychotics such as olanzapine (Zyprexa®) and quetiapine (Seroquel®) have been used off-label for PDP and work by blocking dopamine. However drugs used to treat motor symptoms of Parkinson’s disease increase levels of dopamine. As a result, the off-label use of these antipsychotics is less than ideal for patients suffering from Parkinson’s disease. In contrast, pimavanserin has a different mechanism of action as it is a selective serotonin inverse agonist (SSIA) and acts on serotonin (5-HT2A) receptors. Read more