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Another Drug for Parkinson's Gets Approval

Another Drug for Parkinson's Gets Approval

Recently, the U.S. Food and Drug Administration (FDA) approved a new drug for Parkinson's symptoms called Osmolex ER (amantadine extended release). Osmolex ER is the third amantadine-based medication for Parkinson's disease (PD), and joins amantadine immediate release and Gocovri (amantadine extended release). Amantadine works on two brain chemical systems involved in PD: dopamine and glutamate.

More options can be better, but they also can be confusing. Here we talk about these drugs' similarities and differences and why you might consider one over another.

Let's start with amantadine immediate release. What is that?
This drug is sometimes used alone to treat mild symptoms in early Parkinson's. But doctors often prescribe it for dyskinesia (involuntary, uncontrolled movements) even though it is not specifically FDA approved for that. Amantadine immediate release is taken two or three times per day and may cause insomnia, nausea, dizziness and purple-red blotchy spots on the skin. People with kidney problems might need a lower dose.

What about Gocovri (amantadine extended release)?
This once-a-day formulation is FDA-approved for the treatment of dyskinesia, “off” time (when symptoms are not controlled) or both. Gocovri is taken at bedtime so that the medication levels are highest during the day, when dyskinesia and other symptoms typically are most bothersome.

What is Osmolex ER (amantadine extended release)?
Like amantadine immediate release, Osmolex ER treats Parkinson's symptoms, such as slowness, stiffness and tremor. (It does not have FDA approval for dyskinesia.) Unlike amantadine immediate release , Osmolex ER is taken once a day, in the morning. Potential side effects and the need for a lower dose with kidney problems are similar.

A small group of control volunteers without PD tested Osmolex ER. This study showed that the drug was essentially the same as amantadine immediate release with regard to where it goes in the body and how it works. The FDA approved Osmolex ER based on this and other data comparing the two drugs. (This is how generic drugs are approved too.) As doctors and patients use this medication, we'll learn more about how it's tolerated and how well it works.

Which version of amantadine should you take?
When thinking about any Parkinson's medication, you and your doctor will consider several factors: what symptoms you're treating, a drug's potential side effects and benefits, and cost, for example.

If you're aiming to ease mild symptoms, you and your doctor may consider amantadine immediate release or Osmolex ER. If you have dyskinesia, “off” time or both, you might consider Gocovri. Note that doctors used amantadine immediate release "off label" to treat dyskinesia before Gocovri was available. And some may still do so.

Work with your doctor to find the regimen that works best for you and your symptoms. For more on thinking about newly approved therapies, read our blog. For more on these and other Parkinson's medications, visit our webpage.

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