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Recent FDA Approved Treatment for Parkinson’s Disease in the United States

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Safinamide is recently approved by the FDA for the treatment of Parkinson’s disease as an add-on therapy to levodopa-carbidopa

Recent FDA Approved Treatment for Parkinson’s Disease in the United States
Highlights:
  • Treatment of Parkinson’s disease with levodopa/ carbidopa is characterized by “on” and “off” periods
  • Safinamide could help the patients during the “off” periods
  • Its side effects and contraindications should be understood before prescribing the drug
Safinamide has been recently approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment for Parkinson’s disease.
Patients with Parkinson’s disease have a limited number of options with respect to treatment. There is no cure available for Parkinson’s disease. The levodopa / carbidopa combination is used as the basic treatment to control the symptoms. It helps to maintain the levels of dopamine in the brain, which is reduced in patients with Parkinson’s disease. However, there are times when the combination does not work well and symptoms such as tremors and difficulty with walking re-appear – these are referred to as “off” periods, in contrast to the “on” periods when the medication works well.

The US FDA has approved safinamide to help patients with Parkinson’s disease during these “off” periods. Safinamide prevents the breakdown of dopamine by inhibiting the MAO-B enzyme. Clinical research has revealed that patients with Parkinson’s disease taking the drug as add-on treatment to levodopa-carbidopa experienced more “on” time, with reduction in symptoms in the “off” time. The patients also had better scores of motor function during the “on” time than before.

Side effects of safinamide include high blood pressure, involuntary movements, falls, nausea, sleep disturbances including insomnia or excessive sleep, and eye problems. Behavioral symptoms include problems with impulse control/compulsive behaviors, confusion, hallucinations and psychotic behavior. High fever may occur on stopping the drug. It can cause a dangerous condition called serotonin syndrome when used with certain other medications like MAOIs, antidepressants, opioid drugs, or cyclobenzaprine.

Safinamide should not be prescribed in patients with severe liver disease. It should also not be taken with medications like dextromethorphan, monoamine oxidase inhibitors (MAOI), certain antidepressants, St. John’s Wort and opioid drugs.

The new drug brings hope to the numerous people in the United States who experience fluctuations in symptoms with the conventional treatment for Parkinson’s disease.

Reference:
  1. FDA approves drug to treat Parkinson’s disease - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm547852.htm)


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