FDA Approves Nuplazid (pimavanserin) for Parkinson's Disease Psychosis
The FDA has approved Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. This is the first drug approved specifically for this indication, addressing a significant unmet need in Parkinson's disease management. The approval was based on a 6-week randomized, placebo-controlled trial involving 199 patients with Parkinson's disease psychosis. In the study, Nuplazid 34 mg once daily demonstrated a statistically significant reduction in psychotic symptoms compared to placebo, as measured by the Parkinson's disease-adapted Scale for the Assessment of Positive Symptoms (SAPS-PD). Importantly, the drug did not worsen motor function, a common concern with antipsychotic use in Parkinson's disease. Clinicians should note that Nuplazid is an atypical antipsychotic and carries a contraindication in patients with known hypersensitivity to pimavanserin or its components.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Nuplazid is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. In the clinical trial, patients were aged 40 years or older with a diagnosis of Parkinson's disease (with or without dementia) established at least 1 year prior, and had psychotic symptoms that started after the PD diagnosis and were severe enough to warrant antipsychotic treatment. Patients had a Mini-Mental State Examination (MMSE) score ≥21 and were able to self-report symptoms.
The recommended dose is 34 mg taken orally once daily, without titration. Nuplazid can be taken with or without food. Capsules may be swallowed whole or opened and the entire contents sprinkled over a tablespoon of applesauce, yogurt, pudding, or a liquid nutritional supplement. The mixture should be consumed immediately without chewing. For coadministration with strong CYP3A4 inhibitors, the recommended dose is 10 mg once daily. Concomitant use with strong or moderate CYP3A4 inducers should be avoided.
Efficacy was demonstrated in a 6-week, randomized, placebo-controlled, parallel-group study. 199 patients were randomized 1:1 to Nuplazid 34 mg or placebo. The primary endpoint was change from baseline to Week 6 in SAPS-PD total score. Nuplazid (n=95) showed a least-squares mean change of -5.79 vs placebo (n=90) -2.73, with a placebo-subtracted difference of -3.06 (95% CI: -4.91, -1.20). Effects were seen on both hallucinations and delusions components. Nuplazid did not worsen motor function as measured by UPDRS Parts II+III.
Nuplazid is contraindicated in patients with a history of hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
Nuplazid is the first drug approved specifically for hallucinations and delusions associated with Parkinson's disease psychosis. It offers a treatment option that does not appear to worsen motor function, which is a limitation of other antipsychotics in this population.
View Original Abstract ↓
Intravenous tenecteplase improves functional outcomes but increases hemorrhage risk in non-large vessel occlusion acute ischemic stroke
Tenecteplase improves stroke recovery but increases bleeding risk in late treatment window
Related in Neurology
From Other Specialties
