FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Xadago (safinamide)

Indication:

Add-on treatment for Parkinson disease (PD) in patients who are currently taking levodopa/carbidopa and experiencing “off” episodes.

Mechanism:

Inhibition of MAO-B activity, by blocking the catabolism of dopamine, is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain. The precise mechanism by which it exerts its effect in PD is unknown.

Dosage:

50 mg PO once daily initially. After 2 weeks, may increase dose to 100 mg PO once daily, based on individual need and tolerability.

Approval:

Approval was based on two phase 3 trials that included nearly 1200 patients who had PD with motor fluctuations. Result showed that safinamide as add-on treatment to levodopa/carbidopa provided a significant reduction in off-time and a significant increase in on-time without troublesome dyskinesia in patients experiencing motor fluctuations.

References:

Schapira AH, 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. JAMA Neurol. 2017 Feb 1;74(2):216-24.

Borgohain R, et al. Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations. Mov Disord. 2014 Feb;29(2):229-37.

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