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Table 3. Comparison of Dosing Recommendations for the MAO-B Inhibitors Approved for the Treatment of Parkinson Disease.2-4

Initial dose

Dosage adjustment

Maximum dose
Mild hepatic impairment
(Child-Pugh class A)
Moderate hepatic impairment
(Child-Pugh class B)
Severe hepatic impairment
(Child-Pugh class C)
Concomitant use of
ciprofloxacin

Rasagiline

Safinamide

Selegiline

Monotherapy: 1 mg orally once daily
Adjunct to levodopa with or without
other Parkinson disease drugs: 0.5
mg orally once daily
Adjunct to levodopa with or without
other Parkinson disease drugs:
Increase to 1 mg once daily if
insufficient clinical response
1 mg daily
Maximum dose: 0.5 mg once daily

50 mg orally once daily
without regard to meals

5 mg orally twice daily

Increase to 100 mg once
daily after at least 2
weeks

None

100 mg daily

10 mg/d

Avoid

Maximum dose: 50 mg
orally once daily
Contraindicated

Avoid
Maximum dose: 0.5 mg once daily

Conclusion
Safinamide is approved as adjunctive treatment to carbidopa/
levodopa in patients with Parkinson disease experiencing
"off" episodes. Safinamide's long half-life and high bioavailability allow for once-daily dosing with or without food.
While safinamide showed evidence of short-term efficacy,
long-term study results indicate that the therapeutic benefit
of safinamide may diminish over time. This phenomenon is
observed with most medications available for Parkinson disease, likely due to the progressive nature of the disease.
Safinamide is well tolerated; long-term safety data indicate
that it is safe to use, for at least 2 years. There are currently
no head-to-head trials comparing safinamide with other
selective MAO-B inhibitors.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207145Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207145Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207145Orig1s000ltr.pdf

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