Xadago: Uses, Dosage & Side Effects

A selective, reversible MAO-B inhibitor used as add-on therapy to levodopa for the treatment of mid-to-late stage Parkinson’s disease with motor fluctuations

Rx ATC: N04BD03 MAO-B Inhibitor
Active Ingredient
Safinamide (as methanesulfonate)
Available Forms
Film-coated tablets
Strengths
50 mg, 100 mg
Manufacturer
Zambon S.p.A.

Xadago (safinamide) is a selective and reversible monoamine oxidase type B (MAO-B) inhibitor used as an add-on treatment to levodopa for adults with Parkinson’s disease who experience motor fluctuations. It works by increasing dopamine levels in the brain and modulating glutamate release, helping to extend “on” time and reduce “off” periods. Xadago is taken once daily as a film-coated tablet, starting at 50 mg with the option to increase to 100 mg based on individual clinical response. It requires a prescription and is approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Quick Facts: Xadago

Active Ingredient
Safinamide
Drug Class
MAO-B Inhibitor
ATC Code
N04BD03
Common Uses
Parkinson’s Disease
Available Forms
Oral Tablets
Prescription Status
Rx Only

Key Takeaways

  • Xadago (safinamide) is a selective, reversible MAO-B inhibitor that increases dopamine levels in the brain and modulates glutamate release, providing a unique dual mechanism of action for managing Parkinson’s disease motor fluctuations.
  • It is used exclusively as an add-on therapy to a stable dose of levodopa (alone or with other anti-Parkinson medications) in patients with mid-to-late stage disease experiencing “on-off” fluctuations.
  • Xadago must never be combined with other MAO inhibitors (selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine) or with pethidine; a 7-day washout is required between discontinuation and starting these drugs.
  • The starting dose is 50 mg once daily, which may be increased to 100 mg once daily based on clinical response; patients with moderate hepatic impairment must not exceed 50 mg daily.
  • Patients with certain retinal conditions (including albinism, retinal degeneration, uveitis, inherited retinopathy, or severe progressive diabetic retinopathy) must not take Xadago due to potential risk of retinal damage.

What Is Xadago and What Is It Used For?

Quick Answer: Xadago (safinamide) is a prescription medication used to treat Parkinson’s disease in adults. It is taken as an add-on to levodopa therapy in patients experiencing motor fluctuations (alternating “on” and “off” periods), helping to increase the time patients can move freely.

Xadago contains the active substance safinamide, which belongs to a class of medications known as monoamine oxidase type B (MAO-B) inhibitors. The drug was developed by Newron Pharmaceuticals and is marketed by Zambon S.p.A. It received initial marketing authorization from the European Medicines Agency (EMA) in 2015 and was approved by the U.S. Food and Drug Administration (FDA) in 2017. Xadago represents an important addition to the pharmacological arsenal for managing Parkinson’s disease, particularly for patients in the more advanced stages of the condition.

Parkinson’s disease is a progressive neurodegenerative disorder characterized by the loss of dopamine-producing neurons in the substantia nigra, a region deep within the brain that plays a critical role in movement control. As dopamine levels decline, patients develop the hallmark motor symptoms: tremor at rest, bradykinesia (slowness of movement), rigidity, and postural instability. Levodopa, which is converted to dopamine in the brain, remains the most effective symptomatic treatment. However, as the disease progresses, patients often develop motor fluctuations – predictable or unpredictable periods where levodopa’s effect wears off (“off” periods) before the next dose is due, alternating with periods of good symptom control (“on” periods).

Safinamide works through a dual mechanism of action that distinguishes it from other MAO-B inhibitors. Its primary action is the highly selective and reversible inhibition of MAO-B, the enzyme responsible for the metabolic breakdown of dopamine in the brain. By blocking this enzyme, safinamide reduces dopamine degradation and increases its availability in the striatum, thereby enhancing the effect of levodopa. Unlike selegiline and rasagiline (which are irreversible MAO-B inhibitors), safinamide’s inhibition of MAO-B is reversible, meaning the enzyme function recovers once the drug is eliminated from the body.

The secondary mechanism involves state-dependent blockade of voltage-gated sodium channels. At therapeutic doses, safinamide selectively blocks sodium channels in their inactivated state, which inhibits pathological glutamate release from overactive neurons. Excessive glutamatergic activity has been implicated in both the pathophysiology of Parkinson’s disease and the development of levodopa-induced dyskinesia (involuntary movements). This anti-glutamatergic effect may contribute to the observed clinical benefit of safinamide in managing motor complications without worsening troublesome dyskinesia – a potential advantage over purely dopaminergic add-on therapies.

Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease as add-on therapy to a stable dose of levodopa alone or in combination with other anti-Parkinson medications in mid-to-late stage fluctuating patients. Clinical trials, including the pivotal SETTLE and Study 016/018 trials, demonstrated that safinamide significantly increased daily “on” time without troublesome dyskinesia and reduced “off” time compared with placebo when added to optimized levodopa therapy.

Dual Mechanism of Action

Unlike other MAO-B inhibitors, Xadago combines dopaminergic enhancement (through MAO-B inhibition) with non-dopaminergic glutamate modulation (through sodium channel blockade). This dual approach may help control motor symptoms while potentially reducing the risk of worsening levodopa-induced dyskinesia, offering a differentiated therapeutic profile for patients with motor fluctuations.

What Should You Know Before Taking Xadago?

Quick Answer: Do not take Xadago if you use other MAO inhibitors or pethidine, have severe liver disease, or certain eye conditions affecting the retina. Tell your doctor about all medications, especially antidepressants, cold medicines, and opioids. Xadago should not be used during pregnancy or breastfeeding.

Contraindications

There are several important situations in which Xadago must not be used. Understanding these absolute contraindications is essential for patient safety.

  • Hypersensitivity: Do not take Xadago if you are allergic to safinamide or any of the other ingredients in the tablets (microcrystalline cellulose, crospovidone type A, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol 6000, titanium dioxide, red iron oxide, or potassium aluminium silicate).
  • Other MAO inhibitors: You must not take Xadago if you are currently using any other monoamine oxidase inhibitor, including selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, or tranylcypromine (whether prescribed for Parkinson’s disease, depression, or any other condition). A washout period of at least 7 days is required after stopping Xadago before starting any MAO inhibitor, and vice versa.
  • Pethidine (meperidine): Concurrent use of pethidine, a potent opioid analgesic, is strictly contraindicated due to the risk of serotonin syndrome and other serious adverse reactions.
  • Severe hepatic impairment: Xadago must not be used in patients with severe liver disease (Child-Pugh Class C), as safinamide is extensively metabolized in the liver and its clearance is significantly reduced in these patients.
  • Retinal conditions: Patients with eye conditions that pose a risk of potential retinal damage must not take Xadago. These include albinism (lack of pigment in the skin and eyes), retinal degeneration (progressive cell loss from the light-sensitive layer at the back of the eye), uveitis (inflammation inside the eye), inherited retinopathy (hereditary eye diseases), or severe progressive diabetic retinopathy (progressive vision loss caused by diabetes).

Warnings and Precautions

Before and during treatment with Xadago, speak to your doctor if any of the following apply:

  • Liver problems: If you have any degree of hepatic impairment, your doctor should be informed. Patients with moderate hepatic impairment (Child-Pugh Class B) should not exceed 50 mg per day. Regular liver function monitoring may be recommended.
  • Impulse control disorders: Patients and caregivers should be aware that compulsive behaviors have been reported with dopaminergic medications used in Parkinson’s disease. These may include pathological gambling, increased sexual urges, hypersexuality, compulsive spending or buying, binge eating, and obsessive-compulsive behaviors. If you or your caregiver notice any of these changes, inform your doctor promptly, as dose adjustment or treatment discontinuation may be necessary.
  • Involuntary movements (dyskinesia): Dyskinesia may occur or worsen when Xadago is taken together with levodopa. Your doctor may need to adjust the dose of levodopa or other Parkinson’s medications to manage these movements.
  • Serotonin syndrome: Although Xadago is a selective MAO-B inhibitor, caution is advised when combining it with serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, or dextromethorphan). Watch for symptoms such as confusion, agitation, rapid heartbeat, high blood pressure, hyperthermia, muscle rigidity, and myoclonus.

Pregnancy and Breastfeeding

Xadago should not be used during pregnancy. There are limited data on the use of safinamide in pregnant women, and animal studies are insufficient to rule out potential harm to the developing fetus. Women of childbearing potential must use effective contraception during treatment. If you are pregnant, think you may be pregnant, or are planning to become pregnant, speak with your doctor before using this medicine.

Safinamide is likely excreted in breast milk based on its pharmacological properties. A risk to the breastfed infant cannot be excluded. Therefore, Xadago should not be used during breastfeeding. Your doctor will help you decide whether to discontinue breastfeeding or to discontinue treatment, taking into account the benefit of therapy for you and the benefit of breastfeeding for your child.

Driving and Operating Machinery

Drowsiness and dizziness may occur during treatment with safinamide. You should exercise caution when driving, operating dangerous machinery, or performing other hazardous activities until you are reasonably certain that Xadago does not adversely affect your alertness or coordination. Parkinson’s disease itself can also impair driving ability, and the combination of the disease and its treatments may have additive effects on reaction time and attention. Consult your doctor before driving if you are uncertain.

Children and Adolescents

Xadago is not recommended for use in children and adolescents under 18 years of age. There are no data on the safety and efficacy of safinamide in this population, and Parkinson’s disease does not typically occur in pediatric patients.

How Does Xadago Interact with Other Drugs?

Quick Answer: Xadago must never be combined with other MAO inhibitors or pethidine. Use caution with SSRIs, SNRIs, dextromethorphan, ephedrine, pseudoephedrine, and certain other medications. Xadago may affect the levels of some statins, antibiotics, and antidiabetic drugs through transporter interactions.

Drug interactions with Xadago fall into several categories: absolute contraindications involving serotonergic and MAO-related drugs, precautionary interactions with sympathomimetic agents and antidepressants, and pharmacokinetic interactions through drug transporter proteins. It is essential to tell your doctor about all medications, supplements, and herbal products you are taking before starting Xadago.

Major Interactions

Major Drug Interactions with Xadago
Interacting Drug Effect Clinical Significance
MAO inhibitors (selegiline, rasagiline, moclobemide, phenelzine, tranylcypromine) Risk of hypertensive crisis and serotonin syndrome Absolute contraindication – never combine; 7-day washout required
Pethidine (meperidine) Risk of serotonin syndrome and severe adverse reactions Absolute contraindication – never combine; 7-day washout required
Dextromethorphan (found in cough medicines) Potential risk of serotonergic toxicity and psychosis Avoid combination; use alternative cough treatments
Ephedrine / Pseudoephedrine (decongestants) Potential risk of elevated blood pressure Avoid combination; use alternative decongestants

Precautionary Interactions

Precautionary Drug Interactions with Xadago
Interacting Drug Effect Clinical Significance
SSRIs (e.g., fluoxetine, fluvoxamine) Theoretical risk of serotonin syndrome at high doses Use at the lowest effective SSRI dose; monitor for serotonin syndrome symptoms
SNRIs (e.g., venlafaxine) Theoretical risk of serotonin syndrome Use at the lowest effective SNRI dose; monitor closely
Rosuvastatin, pitavastatin, pravastatin Safinamide inhibits BCRP and OAT3 transporters; potential increase in statin levels Monitor for statin-related side effects (muscle pain)
Ciprofloxacin (fluoroquinolone antibiotic) Potential increase in ciprofloxacin levels via BCRP inhibition Use with caution; monitor for antibiotic side effects
Methotrexate, topotecan Potential increase in drug levels via BCRP inhibition Monitor closely; dose adjustment may be necessary
Diclofenac Potential increase in diclofenac levels via OAT3 inhibition Use with caution; monitor for NSAID side effects
Metformin, glyburide Potential alteration in antidiabetic drug levels via transporter interactions Monitor blood glucose; adjust diabetes medication if needed
Acyclovir, ganciclovir Potential increase in antiviral drug levels via OAT3 inhibition Monitor for antiviral side effects

Safinamide is primarily metabolized by amidase enzymes (non-CYP-dependent), so it is less susceptible to the cytochrome P450-based drug interactions that affect many other medications. However, its metabolites can inhibit breast cancer resistance protein (BCRP) and organic anion transporter 3 (OAT3), which may increase the plasma levels of substrates of these transporters. Your doctor will consider these potential interactions when prescribing or adjusting your medications.

What Is the Correct Dosage of Xadago?

Quick Answer: The recommended starting dose is 50 mg once daily, taken orally with water. After 2–4 weeks, the dose may be increased to 100 mg once daily based on clinical response. Xadago can be taken with or without food, preferably in the morning. Patients with moderate liver impairment must not exceed 50 mg daily.

Always take Xadago exactly as your doctor has instructed. Do not change the dose without consulting your physician. Xadago is available as film-coated tablets and is taken once daily by mouth with water. It can be taken with or without food, and it is generally recommended to take it in the morning to minimize any potential impact on sleep.

Adults

Standard Dosing in Adults

Starting dose: 50 mg once daily, taken orally

Maintenance dose: May be increased to 100 mg once daily after 2–4 weeks based on clinical need and tolerability

Maximum dose: 100 mg once daily

Administration: Swallow whole with water; can be taken with or without food, preferably in the morning

Xadago is always used as an add-on to a stable dose of levodopa (alone or in combination with other anti-Parkinson medications). Your doctor will determine whether dose escalation from 50 mg to 100 mg is appropriate based on your individual response and the overall balance of your Parkinson’s disease medications.

Hepatic Impairment

Dosing in Liver Impairment

Mild hepatic impairment (Child-Pugh A): No dose adjustment required

Moderate hepatic impairment (Child-Pugh B): Maximum dose is 50 mg once daily; do not exceed this dose

Severe hepatic impairment (Child-Pugh C): Xadago is contraindicated and must not be used

If you progress from moderate to severe hepatic impairment during treatment, Xadago must be discontinued immediately.

Elderly Patients

No dose adjustment is required for elderly patients based on age alone. However, clinical experience with safinamide in patients over 75 years of age is limited. Your doctor will consider your overall health status, kidney and liver function, and other medications when determining the appropriate dose.

Kidney Impairment

No dose adjustment is necessary in patients with kidney (renal) impairment. Safinamide is extensively metabolized in the liver before excretion, and kidney function does not significantly affect its clearance.

Children

Xadago is not recommended for use in children and adolescents under 18 years of age due to the absence of safety and efficacy data in this population.

Missed Dose

If you forget to take a dose of Xadago, do not take a double dose to make up for the missed one. Simply skip the forgotten dose and take your next dose at the usual time. Continue with your regular dosing schedule.

Overdose

Stopping Treatment

Do not stop taking Xadago without first consulting your doctor. Abrupt discontinuation of Parkinson’s disease medications can lead to a worsening of symptoms. Your doctor will advise you on how to discontinue the medication safely if needed.

What Are the Side Effects of Xadago?

Quick Answer: The most common side effects of Xadago include insomnia, dyskinesia (involuntary movements), drowsiness, dizziness, headache, worsening of Parkinson’s symptoms, cataract, orthostatic hypotension, nausea, and falls. Serious but rare side effects include hypertensive crisis, neuroleptic malignant syndrome, and serotonin syndrome. Contact your doctor immediately if you experience these.

Like all medicines, Xadago can cause side effects, although not everyone experiences them. The side effects listed below have been reported in patients with mid-to-late stage Parkinson’s disease who were taking safinamide as add-on therapy to levodopa alone or in combination with other anti-Parkinson medications.

Common

May affect up to 1 in 10 people

  • Insomnia (difficulty sleeping)
  • Dyskinesia (difficulty performing voluntary movements)
  • Drowsiness (somnolence)
  • Dizziness
  • Headache
  • Worsening of Parkinson’s disease symptoms
  • Cataract (clouding of the eye lens)
  • Orthostatic hypotension (blood pressure drops on standing)
  • Nausea
  • Falls

Uncommon

May affect up to 1 in 100 people

  • Urinary tract infection, skin cancer
  • Low iron levels, low white blood cell count, abnormal red blood cells
  • Decreased or increased appetite, high blood lipids, high blood sugar
  • Hallucinations, depression, abnormal dreams, anxiety, confusion, mood swings
  • Increased sexual interest, abnormal thoughts, restlessness, sleep disturbance
  • Numbness, unsteadiness, loss of sensation, muscle spasms, speech difficulties
  • Fainting, memory impairment, blurred vision, visual field loss, double vision
  • Light sensitivity, eye redness, increased eye pressure, sensation of spinning
  • Palpitations, rapid heart rate, irregular or slow heartbeat
  • High or low blood pressure, varicose veins
  • Cough, shortness of breath, runny nose
  • Constipation, heartburn, vomiting, dry mouth, diarrhea, abdominal pain
  • Gastritis, flatulence, bloating, drooling, mouth ulcers
  • Excessive sweating, generalized itching, photosensitivity, skin redness
  • Back pain, joint pain, cramps, stiffness, limb pain, muscle weakness
  • Increased nighttime urination, painful urination, erectile dysfunction
  • Fatigue, weakness, unsteady gait, foot swelling, pain, feeling of warmth
  • Weight loss or gain, abnormal blood tests, abnormal ECG, abnormal liver function tests
  • Foot fracture

Rare

May affect up to 1 in 1,000 people

  • Pneumonia, skin infection, sore throat, nasal allergy, dental infection, viral infection
  • Non-cancerous skin changes, abnormal white blood cells, severe weight loss
  • Elevated potassium, uncontrollable urges, clouded consciousness, confabulation
  • Decreased sexual interest, intrusive thoughts, paranoia, premature ejaculation
  • Uncontrollable need to sleep, social phobia, suicidal thoughts
  • Clumsiness, easily distracted, loss of taste, weak reflexes, radiating leg pain
  • Restless legs syndrome, progressive diabetic retinopathy, increased tearing
  • Night blindness, strabismus, heart attack, blood vessel constriction
  • Severely elevated blood pressure, chest tightness, difficulty speaking or swallowing
  • Peptic ulcer, retching, gastrointestinal bleeding, jaundice
  • Hair loss, blisters, skin allergy, bruising, flaking skin, night sweats
  • Skin pain, skin discoloration, psoriasis, spinal inflammation (autoimmune)
  • Joint swelling, musculoskeletal pain, muscle pain, neck pain
  • Urinary urgency, increased urination, pus cells in urine, hesitancy
  • Prostate problems, chest pain, decreased drug effect, drug intolerance
  • Cold sensation, general malaise, fever, dryness of skin, eyes and mouth
  • Heart murmur, bruise or swelling after injury, fat embolism
  • Head injury, mouth injury, skeletal injury, pathological gambling
Reporting Side Effects

It is important to report suspected side effects after the drug has been authorized. This allows ongoing monitoring of the medicine’s benefit-risk balance. You can report side effects to your national pharmacovigilance authority (e.g., EMA in Europe, FDA MedWatch in the United States, or MHRA Yellow Card Scheme in the United Kingdom).

How Should You Store Xadago?

Quick Answer: Store Xadago at room temperature with no special storage requirements. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton and blister. Dispose of unused medication through a pharmacy return program, not via household waste or wastewater.

Keep this medicine out of the sight and reach of children. Do not use Xadago after the expiry date which is stated on the carton and blister pack after “EXP.” The expiry date refers to the last day of that month.

  • Storage conditions: No special storage conditions are required. Store at room temperature.
  • Packaging: Keep the tablets in the original blister pack until ready to use.
  • Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment.

What Does Xadago Contain?

Quick Answer: Each Xadago tablet contains either 50 mg or 100 mg of safinamide (as methanesulfonate). The tablets are orange to copper-colored, round, biconvex film-coated tablets with a metallic sheen, embossed with “50” or “100” respectively.

Active Substance

The active substance is safinamide. Each tablet contains either 50 mg or 100 mg of safinamide in the form of safinamide methanesulfonate (mesylate salt).

Inactive Ingredients (Excipients)

The other ingredients are:

  • Tablet core: Microcrystalline cellulose, crospovidone type A, magnesium stearate, colloidal anhydrous silica
  • Film coating: Hypromellose, macrogol 6000, titanium dioxide (E171), red iron oxide (E172), potassium aluminium silicate (E555)

Appearance and Pack Sizes

Xadago 50 mg tablets are orange to copper-colored, round, biconvex film-coated tablets with a diameter of 7 mm, a metallic sheen, and embossed with “50” on one side. Xadago 100 mg tablets are orange to copper-colored, round, biconvex film-coated tablets with a diameter of 9 mm, a metallic sheen, and embossed with “100” on one side.

Xadago is available in packs containing 14, 28, 30, 90, or 100 film-coated tablets. Not all pack sizes may be marketed in all countries.

Marketing Authorization Holder

Zambon S.p.A., Via Lillo del Duca 10, 20091 Bresso (MI), Italy.

Frequently Asked Questions About Xadago

Xadago (safinamide) is used to treat Parkinson’s disease in adults. It is specifically prescribed as an add-on therapy to a stable dose of levodopa (alone or in combination with other Parkinson’s medications) in patients with mid-to-late stage disease who experience motor fluctuations – periods when they can move well (“on”) alternating with periods of difficulty moving (“off”). Xadago helps to extend “on” time and reduce “off” time.

Xadago has a unique dual mechanism of action. Like selegiline and rasagiline, it inhibits MAO-B to increase dopamine levels. However, unlike those drugs (which are irreversible inhibitors), safinamide’s MAO-B inhibition is reversible. Additionally, Xadago modulates glutamate release through state-dependent sodium channel blockade, which may help control motor symptoms without worsening levodopa-induced dyskinesia. This non-dopaminergic mechanism sets it apart from other MAO-B inhibitors.

You should avoid taking Xadago with cold or cough medicines containing dextromethorphan, ephedrine, or pseudoephedrine, as these may interact with safinamide. Dextromethorphan (a common cough suppressant) can cause serotonergic toxicity when combined with MAO-B inhibitors. Ephedrine and pseudoephedrine (decongestants) may raise blood pressure. Always check the ingredients of over-the-counter medications and consult your doctor or pharmacist before taking any cold or cough remedies.

At the recommended doses of 50–100 mg daily, Xadago is a highly selective MAO-B inhibitor and does not significantly inhibit MAO-A (the enzyme involved in tyramine metabolism). Therefore, unlike older, non-selective MAO inhibitors, no special dietary restrictions regarding tyramine-containing foods (such as aged cheese, cured meats, or fermented products) are required. You can follow a normal diet while taking Xadago. However, if you are unsure, consult your doctor.

Xadago is contraindicated in patients with pre-existing retinal conditions such as albinism, retinal degeneration, uveitis, inherited retinopathy, or severe progressive diabetic retinopathy, because there is a theoretical risk of retinal damage based on its pharmacological properties (inhibition of certain enzymes in the retina). In clinical trials, cataract was reported as a common side effect. Other uncommon visual side effects include blurred vision, double vision, light sensitivity, and visual field loss. Report any changes in vision to your doctor promptly.

In the pivotal SETTLE trial, safinamide 100 mg significantly increased daily “on” time without troublesome dyskinesia by approximately 1.4 hours compared with 0.6 hours for placebo (p < 0.001). It also significantly reduced “off” time. In the long-term Study 016/018, the benefits were sustained over 2 years. Safinamide was also shown to improve motor function scores (UPDRS Part III) and quality of life measures. The drug’s dual mechanism may contribute to these benefits while minimizing worsening of existing dyskinesia.

References

  1. European Medicines Agency (EMA). Xadago (safinamide) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
  2. U.S. Food and Drug Administration (FDA). Xadago (safinamide) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
  3. Schapira AH, Fox SH, Hauser RA, 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 (SETTLE). JAMA Neurol. 2017;74(2):216–224. doi:10.1001/jamaneurol.2016.4467.
  4. Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations (Study 016). Mov Disord. 2014;29(2):229–237. doi:10.1002/mds.25751.
  5. Borgohain R, Szasz J, Stanzione P, et al. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease (Study 018). Mov Disord. 2014;29(10):1273–1280. doi:10.1002/mds.25961.
  6. National Institute for Health and Care Excellence (NICE). Technology Appraisal Guidance TA533: Safinamide for treating Parkinson’s disease. Published 2018.
  7. Fox SH, Katzenschlager R, Lim SY, et al. International Parkinson and Movement Disorder Society Evidence-Based Medicine Review: Update on Treatments for Motor Symptoms of Parkinson’s Disease. Mov Disord. 2018;33(8):1248–1266. doi:10.1002/mds.27372.
  8. World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
  9. Cattaneo C, Sardina M, Bonizzoni E. Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson’s Disease Fluctuating Patients: Post Hoc Analyses of Studies 016 and SETTLE. J Parkinsons Dis. 2016;6(1):165–173. doi:10.3233/JPD-150700.
  10. Tsuboi Y, Hattori N, Yamada T, et al. Long-term safety and efficacy of safinamide as add-on therapy in levodopa-treated Japanese patients with Parkinson’s disease with wearing-off. J Neurol Sci. 2020;415:116891. doi:10.1016/j.jns.2020.116891.

Editorial Team

This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in neurology, movement disorders, and clinical pharmacology.

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