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FDA Accepts Application for New Parkinson’s Treatment, Safinamide (Xadago)

Approval decision expected in December

A new drug application for safinamide (Xadago, Newron Pharmaceuticals/Zambon) has been accepted for filing by the FDA. The agency has set a target date of December 29, 2015 to complete its review.

The application covers the proposed use of safinamide as add-on therapy in patients with early or mid- to late-stage Parkinson’s disease (PD) who are inadequately managed on their current treatment.

Safinamide, an alpha-aminoamide, has both dopaminergic and non-dopaminergic activities in vitro, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism, and inhibition of glutamate release.

PD is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1% to 2% of individuals 65 years of age and older worldwide. The diagnosis of PD is based mainly on the observational criteria of muscular rigidity, resting tremor, or postural instability in combination with bradykinesia. As the disease progresses, the symptoms become more severe.

Early-stage patients are more easily managed on levodopa (L-dopa). L-dopa remains the most effective treatment for PD, and more than 75% of patients with PD receive the treatment. However, long-term use of L-dopa can lead to seriously debilitating motor fluctuations, i.e., phases of normal functioning (ON-time) and decreased functioning (OFF-time). Moreover, as a result of the use of high doses of L-dopa for increasing disease severity, many patients experience involuntary movements known as L-dopa–induced dyskinesia (LID).

As the disease progresses, more drugs are used as add-ons to what the patient already takes, and the focus is to treat symptoms while managing LID and the “off-time” effects of L-dopa. Most current therapies target the dopaminergic system, which is implicated in the pathogenesis of PD, and most current treatments increase dopaminergic transmission, which leads to the amelioration of motor symptoms. There is a growing belief that targeting non-dopaminergic systems may lead to improvements in PD symptoms, such as dyskinesia, that are not improved by current dopaminergic therapies.

Source: Newron Pharmaceuticals; March 2, 2015.


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