The U.S. FDA has approved Rytary (Impax Pharma.), an extended-release oral formulation of carbidopa-levodopa for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism following carbon monoxide or manganese intoxication.
Rytary is meant to reduce the amount of time that Parkinson’s symptoms go uncontrolled, often described as “on” and “off” periods. Rytary is not recommended for patients currently using nonselective monoamine oxidase (MAO) inhibitors.
Rytary was proven effective in two clinical trials, the first which achieved a mean change from baseline in the sum of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II score and UPDRS Part III score for RYTARY versus placebo at Week 30 in 381 patients with early to advanced Parkinson’s.
The second trial showed that treatment with Rytary reduced the percentage of “off” (36.9% to 23.8%) time compared to immediate release carbidopa-levodopa and also increased “on” time (36.0% to 29.8%) without dyskinesia in 393 patients with advanced Parkinson’s. Common adverse effects include nausea, dizziness, headache, insomnia, dry mouth, dyskinesia, constipation, and orthostatic hypotension.
This is the first drug developed and approved for commercialization by Impax. The capsules, which can be swallowed whole or opened and sprinkled on applesauce, contain a 1:4 ratio of extended release beads of carbidopa and levodopa. Rytary will be available in four strengths: 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg (carbidopa/levodopa) and will be distributed starting in February.
Read the full press release here.