Impax Wins FDA Nod For RYTARY ER Capsules For Treatment Of Parkinson's Disease

(RTTNews) - Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (IPXL), said the U.S. Food and Drug Administration 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 inhibitors.

RYTARY contains immediate release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio. It 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, 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg (carbidopa/levodopa) to be available for commercial distribution in February.

The stock surged 12 percent in pre-market activity to $34.70.