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Drug safety evaluation

Efficacy and safety evaluation of safinamide as an add-on treatment to levodopa for parkinson’s disease

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Pages 137-147 | Received 30 Jun 2021, Accepted 30 Sep 2021, Published online: 15 Oct 2021
 

ABSTRACT

Introduction

While levodopa is still the most effective treatment for Parkinson’s disease, concerns about long-term complications such as wearing-off and dyskinesia with levodopa usage remain.

Areas covered

Safinamide is a highly selective and reversible monoamine oxidase B inhibitor introduced in the European Union, Japan, and the United States as an adjunctive agent to levodopa in PD patients with motor fluctuation. This review outlines the pharmacological properties, therapeutic effects, and tolerability of safinamide as an adjunct to levodopa in patients with advanced PD. Efficacy and safety findings from double-blind and placebo-controlled clinical trials for safinamide as an adjunct therapy to levodopa for PD are summarized.

Expert opinion

Safinamide was well tolerated as a treatment for PD, and there was no significant difference in the frequency and severity of adverse events between the safinamide and placebo groups. It was also suggested that safinamide had a beneficial effect on the accompanying non-motor symptoms such as PD-related pain. Safinamide may exhibit neuroprotective effects through antioxidant and anti-glutamate effects, and research on the disease-modifying effect of PD is desired in the future.

Drug Summary

Acknowledgments

We received editorial support in English from LINCSCIENCE.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

K Kurihara and Y Tsuboi were supported by a grant from Nipro Corporation.

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