FDA approves Nourianz for Parkinson�s disease

The FDA has granted approval for Nourianz (istradefylline), from Kyowa Kirin Co, for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes. The FDA approval of Nourianz is based on findings from randomized, multi-center, double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa/carbidopa with or without other PD medications.

The most common adverse reactions with an incidence of at least 5% and occurring more frequently than with placebo were dyskinesia (15%, 17%, and 8%), dizziness (3%, 6%, and 4%), constipation (5%, 6%, and 3%), nausea (4%, 6%, and 5%), hallucination (2%, 6%, and 3%), and insomnia (1%, 6%, and 4%) for Nourianz 20 mg, 40 mg, and placebo, respectively.

Comment: several years ago the FDA found the drug non-approvable as an adjunctive therapy to levodopa/carbidopa for the improvement of motor function in patients with motor response complications, pointing to concerns over whether efficacy findings supported its clinical use Kyowa Hakko is working on a response.