Information About Rytary

The management of Parkinson’s disease is not without its difficulties. The medication levodopa/carbidopa (also known as Sinemet) is still considered the gold standard treatment for the motor symptoms of this disease. But given the fact that Sinemet is short-acting, there are periods between doses where symptoms recur as the drug levels drop. And as the disease progresses, this medication becomes less effective at controlling advancing symptoms. Patients need to take more frequent doses in an effort to avoid “off periods” where the drug effect wears off.

A more beneficial approach would be a formulation that releases levodopa/carbidopa more slowly, giving steadier levels of the medication and reducing the fluctuation of symptoms. This would basically mean less “off time” for Parkinson’s patients.

How It Works

Rytary has been approved in the treatment of Parkinson’s disease. It is an extended-release oral capsule form of carbidopa/levodopa, a drug combination that has been used for decades in its immediate release form (known commonly by the brand name, Sinemet). Unlike its predecessor, with Rytary, both immediate and extended levels of carbidopa/levodopa are found in the blood after a single dose.

Approval for this drug came after the results of two large clinical trials. The first, APEX-PD was a well-designed study (randomized, double-blinded, placebo-controlled) where 381 patients with early Parkinson’s disease received either one of three fixed doses of the drug or placebo for 30 weeks. Results showed that patients who received the drug showed an improvement in motor skills, activity of daily living, and quality of life endpoints.

Differing from the first study, the second clinical trial, ADVANCE-PD enrolled subjects with advanced disease that experienced motor fluctuations or “off time.” Three hundred ninety-three patients were randomized to receive either Rytary or immediate-release carbidopa-levodopa, their mainstay treatment. Those receiving the new medication had significantly less “off time,” resulting in more “on time” without dyskinesias compared to those receiving their normal immediate-release medication.

What Makes Rytary Better?

Rytary is not the first extended-release preparation. Stalevo (which contains levodopa, carbidopa, and entacapone) has been on the market since 2003 and is quite effective for many patients. What makes this new formulation better?

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

Although not the cure that we are waiting for, Rytary does provide one more drug in the clinical toolbox. Your physician will be able to determine whether or not it is appropriate to use it in the management of your disease or whether another medication will give better results.