FDA Approves Extended-Release Oral Treatment for Parkinson's Disease

The US Food and Drug Administration has approved Rytary (carbidopa/levodopa) extended-release capsules for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.

According to Impax Pharmaceuticals, a division of Impax Laboratories, Inc, 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; patients who have trouble swallowing can open capsule, sprinkle the beads on applesauce, and consume it immediately.

Fred Wilkinson, president and CEO, Impax Laboratories, said, 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.”

Rytary will be available in 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg doses (carbidopa/levodopa).

Approval of Rytary was based on safety and efficacy data from several clinical trials. The APEX-PD trial enrolled 381 levodopa-naive patients. Results show that treatment with Rytary met the study’s primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score and UPDRS Part III (motor skills) score for RYTARY vs. placebo at Week 30.

In the ADVANCE-PD study, which enrolled 393 patients with advanced Parkinson’s disease having “off” time, treatment with Rytary reduced the percentage of “off” time (36.9 percent to 23.8 percent) from baseline versus immediate-release carbidopa-levodopa (36.0 percent to 29.8 percent) during waking hours. Treatment with Rytary also increased “on” time without troublesome dyskinesia during waking hours versus baseline to end of study by 1.8 hours.

Common adverse events associated with Rytary treatment in the APEX-PD trial included nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension. Common adverse events reported during the ADVANCE-PD study included nausea and headache. In both trials, these events occurred in at least 5 percent of patients treated with Rytary.

Rytary should not be prescribed for people who are using nonselective monoamine oxidase inhibitors.

Rytary is expected to launch in February 2015.