FDA Gives Nuplazid the Green Light

The FDA has approved the first drug to treat delusions and hallucinations seen in some patients with Parkinson’s disease.

That drug is Acadia Pharmaceuticals’ pimavanserin (Nuplazid), an atypical antipsychotic that works on serotonin 5-HT2A and 5-HT2C receptors.

About half of all patients with Parkinson’s disease experience hallucinations or delusions at some point.

Nuplazid was approval after showing efficacy in a 6-week clinical trial of 199 participants. The drug was demonstrated to be superior to placebo in reducing the frequency and/or severity of hallucinations and delusions, yet it didn’t worsen primary motor symptoms typically seen in Parkinson’s disease.

Nuplazid was previously granted a breakthrough therapy designation. It was given a boxed warning regarding an increased risk of death in older patients with dementia-related psychosis.

Highlights of Nuplazid’s Prescribing Information

Nuplazid is available in tablet form to be given once a day, and it doesn’t require titration.

The recommended dose of Nuplazid is 34 mg (2 17-mg tablets) without regards to food. However, the dose will need to be halved if given concomitantly with strong CYP3A4 inhibitors, and it may need to be increased if given with strong CYP3A4 inducers.

Although the dose doesn’t have to be adjusted for mild to moderate renal impairment, Nuplazid isn’t recommended for those with severe renal impairment or hepatic impairment.

Because Nuplazid may increase the QT interval, its package label recommends avoiding concomitant use with medications that are known to increase the QT interval. Caution should also be exercised if patients have risk factors for prolonged QT interval.

In terms of common side effects, Nuplazid was shown to cause peripheral edema and confusional state.