First drug approved for hallucinations in Parkinson’s

FDA approved the first drug to hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.

Pimavanserin (Nuplazid, Acadia Pharmaceuticals) tablets was granted breakthrough therapy designation for the treatment of hallucinations and delusions associated with Parkinson’s disease.

Related: Study: Reduce long-term care use among patients with Parkinson’s disease psychosis

“Today’s approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson’s disease psychosis,” said Michael S. Okun, MD, medical director of The National Parkinson Foundation. “Through its novel and selective mechanism of action, Nuplazid is a breakthrough treatment that works in a whole new way - treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson’s psychosis patients.”

Hallucinations or delusions can occur in as many as 50% of patients with Parkinson’s disease at some time during the course of their illness.

Nuplazid is the only drug approved by FDA that preferentially targets 5-HT_2A receptors, which are thought to play an important role in Parkinson’s disease psychosis.

Related: Parkinson’s disease: Unmet needs to be fulfilled by novel therapies and reformulations

As a result, the unique pharmacology of Nuplazid establishes a new class of drug-selective serotonin inverse agonists (SSIAs)-by not only preferentially targeting 5-HT_2A receptors but also avoiding activity at dopamine and other receptors commonly targeted by antipsychotics, according to a statement from Acadia Pharmaceuticals.

“Typical Parkinson’s disease therapy consists of drugs that stimulate dopamine to treat patients’ motor symptoms such as tremor, muscle rigidity and difficulty with walking. Nuplazid does not interfere with patients’ dopaminergic therapy and therefore does not impair their motor function,” Acadia said.

The effectiveness of Nuplazid was shown in a 6-week clinical trial of 199 participants, in which the drug was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease.

As with other atypical antipsychotic drugs, Nuplazid has a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis.

In clinical trials, the most common side effects reported by participants taking Nuplazid were swelling, usually of the ankles, legs, and feet due to the accumulation of excessive fluid in the tissue (peripheral edema); nausea; and abnormal state of mind (confused state).

Read more: FDA approves Rytary for Parkinson’s disease