Impax Pharmaceuticals Announces FDA Approval of Rytary Extended-Release Capsules for the Treatment of Parkinson's Disease

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. has announced FDA has approved Rytary, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication. Rytary is not for use in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors.

"The FDA approval of Rytary 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. "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."

"There are approximately one million Americans living with this chronic disease and we are pleased to offer this new therapy as a treatment option for those patients," added Wilkinson. "Today's approval of Rytary is also a significant milestone for Impax because it is our first branded drug internally developed and approved for commercialization."

Rytary contains immediate release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio, and provides both initial and extended levodopa plasma concentrations after a single dose. Rytary may be swallowed whole or, for patients who have trouble swallowing, the capsule may be opened and the beads sprinkled on applesauce and consumed immediately.

Impax expects the four strengths of Rytary, 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg (carbidopa/levodopa) to be available for commercial distribution in February 2015.