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FDA Approves Rytary (Extended-Release Carbidopa/Levodopa) for Treatment of Parkinson’s Disease

Product launch expected in February

The FDA has approved Rytary (Impax Laboratories), an extended-release oral capsule formulation of carbidopa and levodopa, for the treatment of Parkinson’s disease (PD), of post-encephalitic parkinsonism, and of parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication. The combination product is not for use in patients receiving nonselective monoamine oxidase (MAO) inhibitors.

Rytary contains immediate- 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. The capsule may be swallowed whole or, for patients who have trouble swallowing, it may be opened and the beads sprinkled on applesauce and consumed immediately.

Rytary is expected to be available in four strengths –– 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg (carbidopa/levodopa) –– in February.

The Rytary clinical program studied patients with early (levodopa-naïve) to advanced PD in the U.S. and Europe.

The APEX-PD trial, which enrolled 381 levodopa-naïve patients, met its primary efficacy endpoint of a mean change from baseline in the sum of the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (activities of daily living) score and of the UPDRS Part III (motor skills) score for Rytary compared with placebo at week 30 (or early termination).

The ADVANCE-PD trial enrolled 393 patients with advanced PD having “off" time.” The results showed that treatment with Rytary reduced the percentage of “off” time (from 36.9% to 23.8%) from baseline compared with immediate-release carbidopa/levodopa (from 36.0% to 29.8%) during waking hours to the end of the study. Rytary also increased “on” time without troublesome dyskinesia during waking hours compared with baseline to the end of the study by 1.8 hours. Less “off” time was primarily related to more “on” time without troublesome dyskinesia.

The most common adverse events (AEs) associated with Rytary in the APEX-PD trial included nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension. In the ADVANCE-PD trial, the most common AEs were nausea and headache.

PD affects approximately 1 million people in the U.S., with 50,000 to 60,000 new cases diagnosed each year in the U.S. alone. There is currently no cure for the disease.

Source: Impax Laboratories; January 8, 2014.


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