FDA Approves Nourianz to Treat Off Episodes in People with Parkinson’s

The National Institutes of Health (NIH) states that Parkinson’s disease (PD) is the second-most common neurodegenerative disorder in the US, after Alzheimer’s disease.¹ While there is no cure for PD right now, for many people, symptoms are treated with the combination of levodopa and carbidopa. It is not uncommon for those with PD to experience “off” episodes, which are periods when a person's medications aren’t working as well, causing an increase or exacerbation of PD symptoms.¹ This can be emotionally difficult to deal with, and make daily activities more difficult. A new drug called Nourianz^® (generic name: istradefylline) has been approved as an add-on treatment to help during these off episodes. Having fewer symptomatic periods can help improve quality of life and daily living.

What does the evidence show?

The approval of Nourianz on August 27, 2019 was based on results from four randomized 12-week studies that compared Nourianz to a placebo in 1143 people with Parkinson's.² The patients were adults with PD who were taking a stable dose of levodopa/carbidopa, with or without other medications for PD. In all of the studies, those taking Nourianz had a significant decrease from the baseline in daily “off” time when compared with placebo.^1,2 This means they had fewer episodes where their medications weren’t working as well. This is in addition to a 2011 study from Japan where a phase III study of Nourianz showed a significantly reduced “off” time compared to placebo.² There was also an increase in time where medications were effective (“on” time), and less dyskinesia, or involuntary jerking of limbs due to certain medications.²

What is Nourianz?

Nourianz, the brand name for the generic drug istradefylline, is an adenosine A2A receptor antagonist – the first of this drug to be approved to treat PD in the US.² In animal studies, adenosine A2A antagonists effectively reversed motor impairments in lesioned rats when it was combined with l-dopa.³ These drugs facilitate dopamine receptor signaling, helping to normalize motor function. It is also thought that these drugs may also be effective in treating neuropsychiatric components of non-motor symptoms of PD, but more studies are needed.³ It is an oral medication that is taken once daily, and it is to be used in conjunction with levodopa/carbidopa for PD.

As with any medication, there are possible adverse effects or reactions with Nourianz. The most common adverse reactions seen include: involuntary muscle movement (dyskinesia), dizziness, constipation, nausea, hallucination, and sleeplessness.¹ This drug should not be taken during pregnancy, so women of childbearing age should use contraception while being treated with Nourianz. While on this medication, patients should be monitored for the development of or worsening dyskinesia, and if impulsive/compulsive behavior or psychotic behavior occurs, dose reduction or stoppage of the medication should be considered by the treatment team. Every person is different, and while these are potential adverse effects, it doesn’t mean that every person will experience them.

When a new drug comes out, it’s natural for people with Parkinson's to want to try the medication. However, not every drug is suitable or appropriate for every person. If you have questions about whether Nourianz is a possible treatment option for you, talk with your doctor or treatment team. They will be able to look at your past treatments, aspects of your disease, and your medical history to see whether this might be a potential treatment option for you.