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Medicines licensing

Safinamide recommended for approval as Parkinson’s disease therapy

Safinamide has been given the green light by the European regulator to treat certain patients with Parkinson’s disease.

Brain scan of a patient with Parkinson's disease. Safinamide has been recommended for approval as therapy for patients with Parkinson's disease

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Safinamide doesn’t reverse all of the symptoms of Parkinson’s disease, but can improve a patient’s quality of life

A new medicine that allows Parkinson’s disease (PD) patients to spend more of the day symptom-free has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency.

Safinamide has been endorsed by the CHMP for the treatment of adult patients with idiopathic Parkinson’s disease as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD drugs in patients with mid-to-late-stage fluctuating disease.

“The availability of safinamide is great news for patients with Parkinson’s and those involved in their management,” says David Kearney, senior pharmacist in neurology at University Hospitals of Leicester NHS Trust.

Kearney says that although safinamide’s licence is limited, it is indicated for a significant group of patients who are “difficult to manage effectively”.

The CHMP’s decision now needs to be approved by the European Commission.

Long-term treatment with levodopa can eventually lead to fluctuations in control of movement and an increase in involuntary movements, termed dyskinesia. Adding safinamide to levodopa increases the time patients’ symptoms are controlled – so-called “on” time – with little or no troublesome dyskinesia[1].

In trials, frequency of severe dyskinesia was reduced compared with placebo, but overall frequency of dyskinesia was increased. Patients also experienced improvement in motor function. “Although it doesn’t reverse all of the symptoms of Parkinson’s, the demonstrated improvements in ‘on’ time have been shown to improve patient’s quality of life,” says Kearney. Trials have shown that benefits are sustained for two years and that there are no major adverse effects or safety concerns[2].

Safinamide is an alpha-aminoamide that inhibits monoamine oxidase-B, sodium channel blockade and modulates release of glutamate with resulting dopaminergic and non-dopaminergic effects. The medicine is available in two strengths, 100mg and 50mg, both taken once daily. There was no difference between average on and off time between the doses, but the 100mg tablet was associated with an improvement in a score of “activities of daily living”.

“Its once daily dosing schedule will be appreciated in these patients, who already have a significant pill burden to contend with,” says Kearney. “Hopefully it’s just the first of a number of potential new therapies for this all too common but difficult to manage condition.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067595

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