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Safinamide mesylate More Info

Overview:

Safinamide mesylate is an orally administered drug used in the treatment of Parkinson’s disease (PD). It is a selective monoamine oxidase-B (MAO-B) inhibitor with additional non-dopaminergic properties, making it a unique and multifunctional agent. It is primarily used as an add-on therapy to levodopa or other dopaminergic treatments in Parkinson’s patients experiencing “off” episodes.

Brand name: Xadago

Drug class: MAO-B inhibitor (with additional mechanisms)

Approval: Approved by the European Medicines Agency (EMA) in 2015 and the U.S. Food and Drug Administration (FDA) in 2017

Mechanism of Action:

Safinamide mesylate exerts its therapeutic effects through a combination of dopaminergic and non-dopaminergic mechanisms:

MAO-B Inhibition:

Safinamide selectively and reversibly inhibits monoamine oxidase-B, an enzyme responsible for the breakdown of dopamine in the brain.

By inhibiting MAO-B, safinamide increases extracellular dopamine levels, thereby improving motor symptoms in Parkinson’s disease.

Modulation of Glutamate Release:

Safinamide also modulates glutamate release by inhibiting voltage-dependent sodium and calcium channels.

Excess glutamate is thought to play a role in the pathophysiology of PD and its complications, such as motor fluctuations and dyskinesias.

This dual mechanism distinguishes safinamide from other MAO-B inhibitors like selegiline and rasagiline, which do not affect glutamate release.

Indications and Uses:

Safinamide is indicated for the following:

As an adjunct therapy to levodopa (with or without other Parkinson’s medications such as dopamine agonists).

Specifically for adult patients with idiopathic Parkinson’s disease who are experiencing "off" episodes — periods when other medications wear off and symptoms return.

It is not typically used as monotherapy and is most beneficial during the middle to late stages of Parkinson’s disease when motor complications become more common.

Dosage and Administration:

Commonly prescribed doses are 50 mg or 100 mg taken orally once daily.

Treatment typically begins with 50 mg per day and may be increased to 100 mg after two weeks depending on patient response and tolerability.

Can be taken with or without food.

Efficacy:

Clinical trials including the SETTLE and MOTION studies have demonstrated the efficacy of safinamide:

Increased “on” time without troublesome dyskinesia.

Decreased “off” time.

Improved motor functions and global clinical status in combination with levodopa.

Reduced expression of some non-motor symptoms such as pain and depression in some patients.

Side Effects and Safety Profile:

Overall, safinamide is generally well tolerated. Common side effects include:

Dyskinesia (involuntary movements)

Nausea

Insomnia

Falls

Headache

Hypertension

Less common but more serious risks include:

Serotonin syndrome (especially when used with serotonergic drugs)

Increased risk of hallucinations or psychosis in some elderly patients

Eye disorders (retinal changes observed in animal studies, but human relevance unknown)

Contraindications and Cautions:

Contraindicated in patients with severe hepatic impairment.

Should not be combined with other MAO inhibitors or drugs that increase the risk of serotonin syndrome (e.g., SSRIs, SNRIs, certain opioids).

Use with caution in patients with a history of psychiatric disorders or hallucinations.

Pharmacokinetics:

Absorption: Rapidly absorbed after oral administration, peak plasma concentration reached in about 2–4 hours.

Metabolism: Primarily metabolized by amidases and not significantly via CYP enzymes.

Elimination: Excreted primarily in urine; the half-life is approximately 20–26 hours.

Advantages Over Other MAO-B Inhibitors:

Reversible inhibition of MAO-B (unlike rasagiline and selegiline, which are irreversible inhibitors)

Additional glutamatergic modulation may provide benefits in reducing dyskinesia or managing non-motor symptoms

Once-daily dosing with a favorable safety and tolerability profile

Ongoing Research and Developments:

Research is ongoing to assess safinamide’s potential in treating:

Non-motor symptoms in PD (pain, depression, cognitive impairments)

Other neurological conditions, such as restless legs syndrome or chronic pain syndromes

Its neuroprotective effects, although this has not been definitively proven in humans yet

Conclusion:

Safinamide mesylate is a unique and effective adjunct therapy for patients with Parkinson’s disease, especially those experiencing "off" episodes during levodopa treatment. Its dual mechanism — combining reversible, selective MAO-B inhibition and modulation of glutamate release — gives it a distinct advantage over other drugs in its class. With good tolerability and convenient once-daily dosing, safinamide has become a valuable addition to the pharmacological management of Parkinson’s disease.

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