See the DrugPatentWatch profile for xadago
How Xadago Works in Parkinson's Disease
Xadago (safinamide) treats Parkinson's by blocking monoamine oxidase type B (MAO-B), an enzyme that breaks down dopamine in the brain. This inhibition raises dopamine levels in the striatum, the brain region affected by Parkinson's, helping to ease motor symptoms like tremors, rigidity, and slowness of movement.[1]
It acts as an add-on therapy for patients with mid-to-late stage Parkinson's whose symptoms are not fully controlled by levodopa alone. By preserving dopamine, Xadago extends "on" time—the periods when symptoms are under control—without increasing levodopa doses, which can cause dyskinesia (involuntary movements).[1][2]
What Makes Its Mechanism Unique?
Unlike older MAO-B inhibitors like selegiline or rasagiline, safinamide also modulates glutamate release through sodium channel blockade and inhibits dopamine reuptake at higher doses. This dual action on dopaminergic and glutamatergic systems may provide broader symptom relief and reduce off-time more effectively in some patients.[2][3]
Clinical trials showed it increases daily on-time by about 1 hour when added to levodopa, with minimal added dyskinesia compared to placebo.[1]
When Is Xadago Typically Used?
Doctors prescribe it for fluctuating Parkinson's symptoms in adults, usually alongside levodopa/carbidopa and possibly other drugs like dopamine agonists. It's not for early-stage disease or as monotherapy. Dosing starts at 50 mg daily, increasing to 100 mg, taken in the morning with or without food.[1]
Common Side Effects and Risks
Patients report insomnia, nausea, falls, and orthostatic hypotension. It carries a risk of serotonin syndrome if combined with certain antidepressants, and hallucinations can occur. Avoid tyramine-rich foods (like aged cheese) at higher doses to prevent hypertensive crises, though less strictly than with non-selective MAOIs.[1][2]
How Does It Compare to Other MAO-B Inhibitors?
| Drug | Key Difference | Off-Time Reduction |
|------|----------------|-------------------|
| Xadago (safinamide) | Glutamate modulation + MAO-B inhibition | ~1 hour[1] |
| Azilect (rasagiline) | Pure MAO-B inhibitor; neuroprotective claims unproven | ~0.7-1 hour[3] |
| Zelapar (selegiline ODT) | Older; more food restrictions | ~0.5 hour[3] |
Xadago often shows better tolerability in late-stage use but costs more (~$500-600/month without insurance).[2]
Patent and Availability Details
Xadago's main composition patent (US 7,919,509) expires in 2025 in the US, with pediatric exclusivity extending protection slightly. No major challenges listed yet.[4]
[1]: Xadago Prescribing Information (FDA)
[2]: European Medicines Agency Summary (EMA)
[3]: Movement Disorders Review (PubMed)
[4]: DrugPatentWatch.com - Xadago Patents