Impax Pharmaceuticals Announces FDA Approval of Parkinson’s Treatment

Impax Pharmaceuticals, a division of Impax Laboratories, announced on Jan. 8, 2015 that it received FDA approval of Rytary (carbidopa and levodopa), an extended-release oral capsule formulation used for the treatment of Parkinson’s disease, post-encephalitic Parkinsonism, and Parkinsonism following carbon monoxide intoxication and/or manganese intoxication. Rytary is not for use in patients using nonselective monoamine-oxidase inhibitors.

"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. 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," said Fred Wilkinson, president and CEO, Impax Laboratories, in a press release.

Rytary contains immediate-release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio. The beads inside can be added to food via a capsule that is easily opened for patients who cannot swallow the capsule whole.

The first clinical study APEX-PD, which enrolled 381 randomized levodopa-naïve patients with early to advanced Parkinson’s disease, met the primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson’s Disease Rating Scale evaluating activities of daily living and motor skills versus placebo at week 30.

“Off” time is described by the Parkinson’s Disease Foundation as fluctuations in motor skills that result in periods of decreased mobility by those with advanced Parkinson’s. In Study 2, ADVANCE-PD, 393 randomized patients with advanced Parkinson’s experiencing off time showed a reduction in the percentage of off time experienced. In the ADVANCE-PD study, patients experienced reduced off time from baseline versus immediate-release carbidopa-levodopa during waking hours.

This approval comes after a resubmission of the drug to FDA for New Drug Application (NDA) status following an initial denial due to the need for facility re-inspection. In January 2013, a warning letter was issued to a facility that was involved in the production of Rytary. In April 2014, Impax resubmitted the application for NDA, having withdrawn the unsatisfactory facility from production. 

Source: Impax Pharmaceuticals