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Welcome to NUPLAZID StraightTALK

Explore this site to learn the facts about NUPLAZID® (pimavanserin)—the first and only medicine FDA-approved to treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP).

In September 2023, Acadia announced a label update for NUPLAZID. Learn more

In September 2018, the FDA issued a statement reaffirming the positive benefit-risk profile of NUPLAZID for patients with hallucinations and delusions related to Parkinson's disease psychosis. Read more at FDA.gov

nuplazid UPDATE

In September 2023, the FDA updated the NUPLAZID label to clarify its use in patients with Parkinson's disease-related hallucinations and delusions, with or without dementia, and this update is consistent with the current indication.

In September 2018, the FDA issued a statement reaffirming the positive benefit-risk profile of NUPLAZID for patients with hallucinations and delusions related to Parkinson’s disease psychosis. In addition to concluding that NUPLAZID’s benefit-risk profile for these patients remains unchanged, the FDA concluded that patients taking NUPLAZID for PDP should continue to use it as prescribed by their healthcare provider. The FDA reminds healthcare providers to be aware of the risk of QT prolongation (abnormal heart rhythm) associated with NUPLAZID, described in the prescribing information. The FDA also reminded HCPs that no other antipsychotic medication is approved for the treatment of PDP.

See additional Important Safety Information, including Boxed WARNING below

What does NUPLAZID treat?

NUPLAZID is the only treatment approved by the US Food and Drug Administration (FDA) to treat hallucinations and delusions associated with Parkinson's disease psychosis.

NUPLAZID treatment

NUPLAZID was granted Breakthrough Therapy designation for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the FDA in 2014, and subsequently approved in 2016.

What was the NUPLAZID FDA approval based on?

NUPLAZID was approved by the FDA based on data from clinical trials in people with Parkinson's disease (PD)–related hallucinations and delusions. A pivotal trial supported the efficacy and safety of NUPLAZID. The NUPLAZID clinical development program included multiple supportive trials, with over 1200 people receiving NUPLAZID. Of these, 616 were patients with hallucinations and delusions associated with Parkinson's disease psychosis (PDP).

How effective is NUPLAZID

In a pivotal efficacy trial, NUPLAZID significantly reduced the frequency and/or severity of hallucinations and delusions in people with Parkinson’s disease psychosis. The majority of people who took NUPLAZID experienced less frequent and/or less severe symptoms compared with placebo. In addition, taking NUPLAZID did not affect motor symptoms compared to placebo. Not everyone will respond to NUPLAZID.

What is the safety profile of NUPLAZID?

It is important to know about the possible risks and side effects of NUPLAZID, including a Boxed WARNING. See below for more details. NUPLAZID may not be right for everyone. If you have any questions about this medication or this safety information, be sure to discuss with your healthcare provider.