FDA approves drug to treat Parkinson's disease
FDA Press Announcements Mar 29, 2017
The U.S. Food and Drug Administration approved Xadago (safinamide) tablets as an add–on treatment for patients with ParkinsonÂs disease who are currently taking levodopa/carbidopa and experiencing Âoff episodes. An Âoff episode is a time when a patientÂs medications are not working well, causing an increase in ParkinsonÂs symptoms, such as tremor and difficulty walking.
The efficacy of Xadago in treating ParkinsonÂs disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing Âoff time. Those receiving Xadago experienced more beneficial Âon time, a time when ParkinsonÂs symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in Âon time was accompanied by a reduction in Âoff time and better scores on a measure of motor function assessed during Âon time than before treatment.
In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more Âon time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during Âon time than before treatment.
Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. JohnÂs wort, certain antidepressants (such as serotonin–norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life–threatening reaction called serotonin syndrome.
The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep.
Serious, but less common, risks include the following: exacerbated high blood pressure; serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal–emergent hyperpyrexia and confusion; and retinal pathology.
The FDA granted approval of Xadago to Newron Pharmaceuticals.
Go to Original
The efficacy of Xadago in treating ParkinsonÂs disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing Âoff time. Those receiving Xadago experienced more beneficial Âon time, a time when ParkinsonÂs symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in Âon time was accompanied by a reduction in Âoff time and better scores on a measure of motor function assessed during Âon time than before treatment.
In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more Âon time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during Âon time than before treatment.
Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. JohnÂs wort, certain antidepressants (such as serotonin–norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life–threatening reaction called serotonin syndrome.
The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep.
Serious, but less common, risks include the following: exacerbated high blood pressure; serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal–emergent hyperpyrexia and confusion; and retinal pathology.
The FDA granted approval of Xadago to Newron Pharmaceuticals.
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