FDA APPROVES NEW ADD-ON DRUG TO TREAT OFF EPISODES IN ADULTS WITH PARKINSON’S DISEASE

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Istradefylline (Nourianz, Kyowa Kirin) tablets have been approved by the US Food and Drug Administration (FDA) as add-on treatment to levodopa/carbidopa in adults who have Parkinson’s disease (PD) experiencing “off” episodes. 


Eric Bastings, M.D., acting director of the Division of Neurology Products in the FDA’s Centre for Drug Evaluation and Research said “Parkinson’s disease is a debilitating condition that profoundly impacts patients’ lives.”

Istradefylline is a selective adenosine A2A receptor antagonist. When treated on ‘off’ episodes in patients with PD taking levodopa/carbidopa its effectiveness was shown in four 12-week, placebo-controlled clinical studies that included a total of 1143 participants.

According to all the four studies, it reports that the addition of istradefylline leads to a statistically significant decrease from baseline in daily “off” time relative to placebo add-on, the FDA stated in a news release.

Dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia were the most common adverse reactions observed in patients who consumed istradefylline. Patients should be monitored for the development of dyskinesia or exacerbation of existing dyskinesia. The FDA advises considering reducing the dose or stopping the drug usage if hallucinations, psychotic behaviour, or impulsive/compulsive behaviour occurs.

PD is the second most common neurodegenerative disorder in the United States after Alzheimer’s disease according to the National Institutes of Health. 50,000 Americans are estimated to be diagnosed with PD each year, and about 1 million Americans have the condition.


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