Trial Data on Rytary and Off Episodes in Advanced Parkinson’s Being Given at AAN

Ana de Barros, PhD avatar

by Ana de Barros, PhD |

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Impax Laboratories is presenting data on its approved Parkinson’s disease treatment, Rytary, as well as findings in a clinical trial assessing a version of this extended-release carbidopa and levodopa mixture (IPX203) in people with advanced disease symptoms, including possible improvements in daily activities and quality of life.

The presentations began Sunday and run through Wednesday at the American Academy of Neurology conference, in Boston through April 28.

A randomized Phase 2b study (NCT03007888) is assessing single and multiple doses of IPX203 — compared to immediate release carbidopa-levodopa — to determine the drug’s pharmacokinetics and pharmacodynamics in up to 30 patients with advanced Parkinson’s disease (PD). The primary goal is measuring the percentage of off-time episodes during waking hours as noted in patient diaries and clinical assessments, and reports of quality of life. Off-time is the name given to daytime periods when medication begins wearing off.

Among other findings, the company is presenting results that show treatment with IPX203 led to improved daily living activities and quality of life measures.

Parkinson’s is a chronic and progressive neurological disease in which the nerve cells that produce dopamine are damaged and unable to produce enough, leading to a variety of symptoms and problems associated with movement, such as tremors (shaking), stiffness and slowed movement. A primary PD treatment is levodopa (L-dopa), which belongs to a class of drugs called central nervous system agents and works by being converted to dopamine in the brain.

Doctors usually prescribe levodopa with carbidopa to Parkinson’s patients. Carbidopa is part of a class of drugs called decarboxylase inhibitors, which prevent levodopa from breaking down before it reaches the brain. It allows for lower doses of levodopa, resulting in fewer side effects such as nausea and vomiting.

Rytary, an extended release oral capsule formulation of carbidopa and levodopa, was approved by the  U.S. Food and Drug Administration in January 2015 to treat Parkinson’s and parkinsonism. Clinical trial results showed significant improvement in daily life activities in early to moderate PD treated with Rytary, and significantly fewer off-time episodes in those with advanced disease, the company reports on its website.

Impax will also present data from its FDA-approved Zomig nasal spray for use in pediatric patients 12 and older for the acute treatment of migraine with or without aura.

“This is an important meeting for our specialty pharma division that markets Rytary and Zomig nasal spray.  It underscores our commitment to advancing the science for treating neurological disorders,” Paul Bisaro, Impax president and chief executive officer, said in a press release.

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