A recent retrospective analysis published in Drug Safety showed lower all-cause mortality risk among Parkinson’s disease Psychosis (PDP) patients treated with NUPLAZID® (pimavanserin) compared to those treated with other atypical antipsychotics. This is notable because NUPLAZID is the only FDA approved treatment for PDP and NUPLAZID stands alone among atypical antipsychotics in targeting key serotonin receptors versus dopamine.
DocWire News spoke with Ponni Subbiah, Chief Medical Officer, Acadia Pharmaceuticals Inc, about this study.
DocWire News: Provide us with some brief background on yourself, and your specialty.
Dr. Ponni Subbiah: My name is Ponni Subbiah. I’m a neurologist and Senior Vice President of Medical Affairs and Chief Medical Officer at Acadia.
What are the challenges of treating patients with Parkinson’s disease psychosis? Do traditional antipsychotic treatments come with a risk?
Yeah, so, Parkinson’s disease psychosis is composed of hallucinations and delusions. They’re considered non-motor symptoms of Parkinson’s disease. In fact, they can be more disruptive and disabling than the motor symptoms because they can lead to fear and anxiety in the patient and be very disruptive in their lives as well as in their families. And it’s very important that also to note that Parkinson’s disease psychosis actually causes increased risk of mortality.
In one study, there was a 34% increased risk when a patient with Parkinson’s disease has psychosis versus those that don’t have the psychosis. So it’s very important that these symptoms get detected early, diagnosed, and managed.
Now to the second part of your question, with regards to antipsychotic use, as I mentioned, these symptoms do need to be treated. Now, in the US, the only drug that’s been approved by the FDA for treatment of psychosis in Parkinson’s disease is NUPLAZID or pimavanserin. Now, other drugs also used other antipsychotics, but they’re used off-label.
And why it’s important when you treat these patients is to keep the profile of the drugs in mind. So NUPLAZID works through the serotonergic system. It’s very specific for that system and has negligible activity in other neuroreceptors, such as dopamine receptors, which is important because NUPLAZID is less likely to cause cognitive impairment or motor impairment, which are very important in a disease such as Parkinson’s, which is neurodegenerative in nature.
Can you describe the Drug Safety study and why you compared NUPLAZID with other atypical antipsychotics?
So in this elderly fragile population in Parkinson’s disease, it’s very important, as we’ve done with all drugs, we continuously monitor the safety of the product. And since the launch of NUPLAZID in 2016, we have a wealth of now data that looks at the safety of the drug. But we continue to monitor that as long as the drug is in the market.
So in that spirit, we did a real world observational study using the Medicare database. It’s actually quite a large study, with about 3000 patients in each arm. And in that, the results showed there was a lower risk of all cause mortality in the group that was treated with NUPLAZID versus other atypical antipsychotics. In fact, there was a 22% risk reduction of this risk of mortality, which translates into a very important point that clinicians need to keep in mind during their decision-making process when they’re providing care for these patients.
What are the clinical implications of these findings?
I think one is that, as I mentioned, there was a decrease in risk of all cause mortality. But this was seen not just overall in the group, but this trend also show that was demonstrated regardless of sex or regardless of dementia diagnosis or age of the patient.
Another important point that’s important is this trend was not only in the general community setting, but this trend in difference in mortality was also seen in those patients who resided in nursing homes or in skilled nursing facilities, which was about 30% of the group.
Any key takeaways?
Yeah, there’s a couple of things I want to make sure that our audience remembers. One is Parkinson’s disease psychosis is really critical. They can be very disruptive for the patients. It needs to be diagnosed and managed early. Number two, it’s really important to keep in mind that pimavanserin is the only drug that’s been approved for the treatment of these symptoms. And this study, it’s important to keep in mind that without treatment, there’s an increased risk of mortality in these patients just by the occurrence of psychosis.
So that’s why the results from the study are important because it shows that decreased risk of mortality in this study compared with pimavanserin compared with the other antipsychotics.