FDA Approves Supplementary Treatment For Parkinson’s Disease “Off” Episodes

A recent publication from the US Food and Drug Administration announced the regulatory authority’s approval of Nourianz (generic name istradefylline) for Parkinson’s patients during “off” episodes. “Off” episodes are windows of time when patients’ medications aren’t working as well as they should, leading to pronounced symptoms.

About Parkinson’s Disease

Parkinson’s disease is a progressive neurological disorder involving significant portions of the brain. It is characterized by the gradual breakdown and death of certain neuron clusters, eventually leading to significant motor and cognitive difficulties. Tremors, stiffness, speech difficulties, and decline in automatic muscle functions like blinking or breathing may occur.

Many of the areas affected are involved with the production of dopamine, a major neurotransmitter that plays important roles in motor control and certain essential cognitive functions. When dopamine-producing cells die, the resulting chemical changes in the brain can lead to many of the symptoms associated with Parkinson’s.

Although Parkinson’s is not itself fatal, the complications can be serious and in some instances can lead to early morbidity. Several treatments exist that can help limit the severity of certain associated symptoms, but there is currently no cure.

About “Off” Episodes and Nourianz

Levodopa is one of the main drugs used to limit the symptoms of Parkinson’s in patients. It works by providing an artificial source of dopamine to the brain to normalize function. Because dopamine is too large a molecule to pass through the highly selective blood-brain barrier, the drug is instead based on a smaller molecule that is metabolized into dopamine once in the brain.

While often effective, over time the body’s ability to convert levodopa to dopamine becomes reduced. Simply put, after a while, the drug stops working as well. This window of decreased efficacy is called an “off” episode. Add-on treatments like Nourianz are being developed to provide a short-term regular alternative to levodopa.

Nourianz is distributed as an orally-administered tablet that helps Parkinson’s patients control their symptoms during “off” episodes. The FDA’s recent approval came as the end result of four different three-month placebo-controlled clinical trials involving over 1,000 volunteers with Parkinson’s. In each trial, participants who received Nourianz had significantly shorter “off” episodes compared to the control arm.

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