Xadago (safinamide)

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Xadago (safinamide)

Xadago (safinamide) is a medication used as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.

How to buy Xadago (safinamide): You can order Xadago (safinamide) from TheSocialMedwork if the drug has not been approved or is not available in your country.

Neurology Parkinson's Disease
Marketing Authorisation Holder Zambon SpA
Mode of Action Monoamine Oxidase-B (MAO-B) inhibitor
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA

What is Xadago (safinamide) for?

Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor, indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes2.

How does Xadago (safinamide) work?

Parkinson’s disease develops when neurons (brain cells) in a particular part of the brain stop working properly and are lost over time. These neurons produce an important chemical called dopamine. Dopamine is used by the brain to send messages across brain areas to help control movement. Eventually, the brain cannot make enough dopamine to control the movement properly. There is currently no cure for Parkinson’s Disease. Existing treatments aim to help patients manage symptoms4.

The active substance in Xadago - safinamide - blocks the enzyme MAO-B which breaks down dopamine, thereby helping to restore dopamine levels in the brain and improving the patient's symptoms5.

Where has Xadago (safinamide) been approved?

Xadago (safinamide) was approved as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes by:

  • Food and Drug Administration (FDA), USA, March 21, 20171

  • Medical Agency (EMA), European Union, February 24, 20175.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Xadago (safinamide) taken?

The standard dosage is2,3:

  • Start dose: 50 mg once daily at the same time of day

  • After two weeks, the dose may be increased to 100 mg once daily, based on individual's need and tolerability

Warning: Do not exceed 50 mg once daily in patients with moderate hepatic impairment; this medicine is contraindicated in patients with severe hepatic impairment.

Complete information about Xadago (safinamide) dosage and administration can be found in the official prescribing information listed in our resources section2,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Xadago (safinamide)?

Common side effects

The most common side effects listed in the prescribing information include2,3:

  • insomnia

  • dyskinesia (difficulty controlling movement)

  • somnolence

  • dizziness

  • nausea.

Serious side effects

Safinamide must not be used in patients with severe liver problems, in patients treated with pethidine or other MAO inhibiting medicines2,3.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information2,3.

More Information
Working ingredient safinamide
Shipping method Standard (not temperature controlled)
Therapeutic Area Neurology
Neurology Parkinson's Disease
Indication Parkinson's disease
Administration Oral
Mode of Action Monoamine Oxidase-B (MAO-B) inhibitor
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Zambon SpA

The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals of Xadago (safinamide) for Parkinson’s disease in patients experiencing “off” episodes were based on two main studies. These studies involved a total of 1,218 patients with late stage Parkinson’s disease who experienced fluctuations in their status.

Results

In both studies, 6 months treatment with Xadago increased the time during the day during which patients were ‘on’ and able to move by 30 - 60 minutes when compared with placebo5.

In study 1 (016), which lasted for 24 weeks, patients received either safinamide 50 mg/day (N = 217 patients), safinamide 100 mg/day (N=216 patients), or placebo (N= 212 patients). Patients on the placebo group had an average additional ‘on’ time of 0.5 ± 0.2 hours, compared to 1.0 ± 0.2 in patients on safinamide 50 mg, and 1.2 ± 0.2 in patients on safinamide 100 mg2,3.

In study 2 (016/018), which lasted for 2 years, patients received either safinamide 50 mg/day (N = 223 patients), safinamide 100 mg/day (N=224 patients), or placebo (N= 222 patients). Patients on the placebo arm had an average additional ‘on’ time of 0.8 ± 0.2 hours, compared to 1.4 ± 0.2 in patients on safinamide 50 mg, and 1.5 ± 0.2 in patients on safinamide 100 mg2,3.


1. FDA approves drug to treat Parkinson’s disease
    FDA, March 2017

2. Summary of Product Characteristics [FDA]: Xadago (safinamide) [PDF]
    US WorldMeds, LLC, March 2017

3. Summary of Product Characteristics [EMA]: Xadago (safinamide) [PDF]
    Zambon SpA, April 2017 

4. Parkinson's
    Parkinsons UK, cited May 2017 

5. Human Medicines: Xadago (safinamide)
    EMA cited May 2017 

Shipping Type Standard
Shipping method Standard (not temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.