FDA Approves Rytary for Parkinson's Disease
Impax announced that the Food and Drug Administration (FDA) has approved Rytary (carbidopa/levodopa) extended-release capsules for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.
Rytary capsules contain both immediate-release and extended-release beads in a fixed 1:4 carbidopa to levodopa ratio. The capsules may also be opened and the beads sprinkled on applesauce for patients who have trouble swallowing.
The approval of Rytary was based on the Rytary clinical program that evaluated patients with early (levodopa-naive) to advanced Parkinson's disease. Results from the APEX-PD (Study 1) study of 381 levodopa-naive patients met the study's primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score and UPDRS Part III (motor skills) score vs. placebo at Week 30. In ADVANCE-PD (Study 2), treatment with Rytary decreased the percent of "off" time from 36.9% to 23.8% from baseline vs. immediate-release carbidopa/levodopa (36.05 to 29.8%) during waking hours to end of study.
Rytary will be available in 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg capsules. It is expected to launch in February 2015.
For more information call (877) 994-6729 or visit ImpaxLabs.com.