This article is more than 5 years old. Information may no longer be current.
FDA approves Nourianz for Parkinson’s disease
Click Here to Manage Email Alerts
The FDA has approved Nourianz tablets as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who are experiencing "off" episodes, according to a press release.
Nourianz (istradefylline, Kyowa Kirin Inc.), an adenosine A2A receptor antagonist, is a nondopaminergic pharmacological treatment, according to its manufacturer.
“FDA approval of Nourianz is an important milestone,” Tom Stratford, president of Kyowa Kirin USA Holdings Inc., said in a company press release.
The approval is based on four 12-week placebo-controlled clinical studies that included 1,143 patients with Parkinson’s disease. Patients took istradefylline and a stable dose of levodopa/carbidopa with or without other Parkinson’s disease medications. They experienced a statistically significant decrease from baseline in daily off time compared with patients receiving a placebo, according to the FDA.
The FDA said the most common adverse events among those who received istradefylline were constipation, dizziness, dyskinesia, hallucination, insomnia and involuntary muscle movement. In addition, women of childbearing age should be advised to use contraception during treatment, and women who are pregnant are not advised to use the drug.
Disclosure: Stratford is employed by Kyowa Kirin.