FDA Approves Parkinson's Disease Treatment

The FDA today approved carbidopa-levodopa (Rytary), an extended-release oral capsule formulation, to treat Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.

Impax Pharmaceuticals is planning on having 4 strengths of Rytary available in February 2015.

The newly approved treatment could help the 1 million individuals in the United States with Parkinson’s.

“The FDA approval of Rytary (pronounced rye-TAR-ee) is an important new development for the treatment of Parkinson’s disease and provides an extended-release carbidopa-levodopa product that treats Parkinson's disease,” said Fred Wilkinson, president and CEO, Impax Laboratories, in a press release. “Rytary is designed to address one of the most significant unmet needs for patients living with Parkinson's disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled.”

A study of Rytary met primary efficacy endpoints of mean change from baseline using the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II, which measures activities of daily living, and the UPDRS Part III, which measures motor skills, in comparisons between Rytary and placebo at week 30.

Another study of 393 patients with advanced Parkinson’s showed Rytary helped reduce “off” time and increased “on” time without dyskinesia, according to Impax.

Side effects of Rytary include nausea, dizziness, headache, and insomnia.

Impax reported Rytary should not be used by patients on nonselective monoamine oxidase inhibitors.

Rytary can be swallowed whole or opened and sprinkled on food if patients have trouble swallowing.