safinamide (Xadago)
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Indications
- adjunctive treatment for patients with Parkinson's disease who experience "off" episodes with levodopa/carbidopa[1]
Contraindications
- severe liver problems[1]
Dosage
Adverse effects
- most common
- uncontrolled involuntary movement
- falls
- nausea
- insomnia[1]
- less common
- exacerbation of hypertension
- serotonin syndrome when used with MAO inhibitors, antidepressants, or opiates
- narcolepsy
- hallucinations & psychosis
- impulse control/compulsive disorder
- withdrawal-emergent hyperpyrexia & confusion;
- retinopathy[1]
- drug adverse effects of MAO inhibitors
- drug adverse effects of antidepressants
- drug adverse effects of psychotropic agents
Drug interactions
- dextromethorphan, MAO inhibitor, opiates, St John's wort, SSRIs, tricyclic antidepressants, tetracyclics, triazolopyridines, or cyclobenzaprine in combination may result in life-threatening serotonin syndrome[1]
- drug interaction(s) of benzodiazepines with antidepressants
- drug interaction(s) of antidepressants with benzodiazepines
- drug interaction(s) of beta-adrenergic receptor antagonists with MAO inhibitors
- drug interaction(s) of NSAIDs with antidepressants
- drug interaction(s) of MAO inhibitor with caffeine
Mechanism of action
Clinical trials
- on time without troublesome dyskinesia longer with safinamide than with placebo[2] (manufacturer-supported phase III study)
More general terms
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 Brooks M FDA Okays Safinamide (Xadago) for Parkinson's Disease Medscape. March 21, 2017 http://www.medscape.com/viewarticle/877524
FDA News Release. March 21, 2017 FDA approves drug to treat Parkinson's Disease. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm547852.htm
Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871
U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm - ↑ 2.0 2.1 Schapira AHV et al. Assessment of safety and efficacy of safinamide as a levodopa adjunct in patients with Parkinson Disease and motor fluctuations: A randomized clinical trial. JAMA Neurol 2017 Feb 1; 74:216 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27942720
- ↑ Borgohain R, Szasz J, Stanzione P et al Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations. Mov Disord. 2014 Feb;29(2):229-37. Epub 2013 Dec 9. PMID: https://www.ncbi.nlm.nih.gov/pubmed/24323641 Free PMC Article