Officials from the FDA have approved of a new add-on treatment to levodopa/carbidopa in adult patients with Parkinson disease (PD). Istradefylline tablets (Nourianz, Kyowa Kirin) are indicated to assist patients who are experiencing 'off' episodes, better defined as a time when a patient’s medications are not working well and symptoms, such as tremors and difficulty walking, are increased.1

The effectiveness of istradefylline was tested in four 12-week placebo-controlled clinical studies that included 1,143 participants. In each study, patients who were treated with Nourianz experienced a significant decrease from their baseline in daily “off” time compared to patients receiving a placebo.1

The most common adverse reactions observed in patients taking istradefylline were involuntary muscle movement, dizziness, constipation, nausea, hallucination and sleeplessness. Patients should be monitored for development of dyskinesia or exacerbation of existing dyskinesia. If hallucinations, psychotic behavior, or impulsive/compulsive behavior occurs, a dosage reduction or stoppage of istradefylline should be considered. Use of istradefylline during pregnancy is not recommended.1 

PD is the second-most common neurodegenerative disorder in the U.S. and affects 50,000 Americans each year, typically over the age of 60. It occurs when the cells in our brain that produce dopamine become impaired or die.1 Early symptoms of the disease include trouble sleeping, tremor, loss of smell, and hunching over.2

  1. FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease [news release]. Silver Spring, MD; August 27, 2019: FDA website. Accessed August 28, 2019. 
  2. 10 early signs of Parkinson’s disease. The Parkinson’s Foundation website. Published 2019. Accessed August 28, 2019.