Xadago (safinamide)

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Xadago (safinamide)

How to buy Xadago: You can order Xadago (safinamide) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Zambon
Disease Parkinson's Disease
Indication Parkinson's Disease
Mode of Action Monoamine Oxidase-B (MAO-B) inhibitor
Approval Status EMA approved (EU); FDA approved (USA)
CAS Number 1257044-40-8
HS Code 29331990
Strength 50 mg, 100 mg

Who is safinamide for?

Xadago (safinamide) is indicated as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking [1].

Recommended dose

Complete information about Xadago (safinamide) dosage and administration can be found here: [2][3].
The standard dosage is:
  • 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
Do not exceed 50 mg once daily in patients with moderate hepatic impairment; this medicine is contraindicated in patients with severe hepatic impairment.
Consult your treating doctor for personalised dosing.

What is safinamide and how does it work?

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” episodes [2].
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 symptoms [4].
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 symptoms [5].

What is safinamide's approval status?

Xadago (safinamide) was approved by:
  • FDA (USA) on March 21, 2017 [1]
  • EMA (EU) on February 24, 2017 [5]
as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
The approval of Xadago (safinamide) for Parkinson’s disease was based on two main studies involving a total of 1,218 patients with late stage Parkinson’s disease who experienced fluctuations in their status. 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 placebo [5].
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 mg [2][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 mg [2][3].
Among the most common side effects with safinamide are insomnia, dyskinesia (difficulty controlling movement), somnolence, dizziness, and nausea [2][3]. Safinamide must not be used in patients with severe liver problems, in patients treated with pethidine or other MAO inhibiting medicines [2][3].
References
[1] FDA News Release: FDA approves drug to treat Parkinson’s disease, 21/03/2017.
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm547852.htm
[2] Summary of Product Characteristics [FDA]: Xadago (safinamide), US WorldMeds, LLC, Mar. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145lbl.pdf
[3] Summary of Product Characteristics [EMA]: Xadago (safinamide), Zambon SpA, Apr. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002396/WC500184965.pdf
[4] Parkinsons.UK, cited on 10/05/2017.
https://www.parkinsons.org.uk/content/treatments-and-therapies-parkinsons
[5] EMA. Human Medicines: Xadago (safinamide), 30/03/2015 (last update: 5/04/2017), cited on 10/05/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002396/human_med_001847.jsp&mid=WC0b01ac058001d124








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