FDA approves Rytary for Parkinson’s disease

FDA approved an extended-release oral capsule formulation of carbidopa-levodopa (Rytary, Impax Pharmaceuticals, a division of Impax Laboratories, Inc.)  for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.

FDA drug approvals-January 2015

Rytary is not for use in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors.

According to the National Parkinson Foundation, in the United States, 50,000 to 60,000 new cases of Parkinson’s are diagnosed each year, adding to the 1 million people who currently have Parkinson’s. The Center for Disease control rated complications from Parkinson’s disease as the 14th leading cause of death in the United States. Worldwide, it is estimated that 4 to 6 million people suffer from the condition. 

“The FDA approval of Rytary has the ability to provide longer and better symptoms control for individuals with Parkinson's disease, and offer the opportunity for an improved quality of life,” said FormularyWatch Advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

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.

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In February 2015, 4 strengths of Rytary including 23.75 mg/95 mg; 36.25 mg/145 mg, 48.75 mg/195 mg; and 61.25 mg/245 mg (carbidopa/levodopa) is expected to be available for commercial distribution.

The Rytary clinical program studied patients with early (levodopa-naive) to advanced Parkinson's disease in the United States and in Europe. In APEX-PD (Study 1), a trial that enrolled and randomized 381 levodopa-naive patients, the study met its primary efficacy end point 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 versus placebo at Week 30 (or early termination).

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In ADVANCE-PD (Study 2), a trial of 393 randomized patients with advanced Parkinson's disease having "off" time, the results showed treatment with Rytary reduced the percentage of "off" time (36.9% to 23.8%) from baseline versus immediate-release carbidopa-levodopa (36.0% to 29.8%) during waking hours to end of study. Rytary also increased "on" time without troublesome dyskinesia during waking hours versus baseline to end of study by 1.8 hours. Less "off" time was primary related to more "on" time without troublesome dyskinesia.

Nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension, were the most common adverse reactions with Rytary in the APEX-PD trial (in at least 5% of patients and more frequently than in placebo) were. The most common adverse reactions with Rytary in the ADVANCE-PD trial (in at least 5% of patients and more frequently than an oral immediate-release carbidopa-levodopa) were nausea and headache.