Posted by Michael Wonder on 27 Aug 2019
FDA approves new add-on drug to treat off episodes in adults with Parkinson's disease
27 August 2019 - The U.S. FDA today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes.
An "off" episode is a time when a patient's medications are not working well, causing an increase in Parkinson's disease symptoms, such as tremor and difficulty walking.
The effectiveness of Nourianz in treating "off" episodes in patients with PD who are already being treated with levodopa/carbidopa was shown in four 12-week placebo-controlled clinical studies that included a total of 1,143 participants. In all four studies, patients treated with Nourianz experienced a statistically significant decrease from baseline in daily "off" time compared to patients receiving a placebo.
