The U.S. Food and Drug Administration has approved Nourianz (istradefylline) tablets for the treatment of adult patients with Parkinson’s disease. The drug is given in combination with levodopa/carbidopa during “off” periods. An “off” period is a time when the drugs don’t function, and the patients experience tremors and difficulty in walking.
Parkinson’s disease is the most common neurodegenerative disease after Alzheimer’s disease in the United States. The incidence of PD is 50,000/year. Cell producing the dopamine die or impair resulting in PD. The symptoms worsen gradually.
The efficacy was studied in four 12-week placebo-controlled studies involving 1,143 participants. In all the trials, patients experience significant “off” periods compared to the placebo-controlled studies.
The adverse events reported are involuntary muscle movement, dizziness, constipation, nausea, hallucination, and insomnia.