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safinamide (Xadago)
Indications:
- adjunctive treatment for patients with Parkinson's disease who experience "off" episodes with levodopa/carbidopa [1]
Contraindications:
- severe liver problems [1]
Dosage:
- start 50 mg PO QD
- may increase to 100 mg PO QD after 2 weeks if clinically indicated
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 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]
Mechanism of action:
- MAO-B inhibitor [1]
Clinical trials:
- on time without troublesome dyskinesia longer with safinamide than with placebo [2] (manufacturer-supported phase III study)
Interactions
drug adverse effects of MAO inhibitors
General
monoamine oxidase [MAO] inhibitor
neurologic agent
amide
amine
ether
aromatic compound
Database Correlations
PUBCHEM cid=131682
References
- 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
- 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: 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: 24323641 Free PMC Article