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Safinamide Shows Promise as Add-On to Levodopa in Parkinson’s Patients

Phase III trial analyzes change in daily ‘on’ time (June 19)

Positive results from a phase III trial of safinamide (Newron Pharmaceuticals) were presented at the 17th International Congress of Parkinson’s Disease and Movement Disorders, held June 16–20 in Sydney, Australia.

Safinamide was associated with clinically important improvements in motor symptoms — i.e., improvements of more than 1 hour in the patient- and caregiver-rated ON and OFF time plus 30% or greater improvement in motor symptoms — as an add-on therapy to levodopa and other dopaminergic treatments in patients with Parkinson’s disease (PD). These improvements were achieved in a significantly greater proportion of patients treated with safinamide than in those given standard of care (P = 0.018).

In addition, safinamide showed a rapid onset of efficacy, with significant improvements being observed in ON time (P = 0.0003) and OFF time (P < 0.0001) from week 2 onwards.

The SETTLE trial was a 6-month, randomized, double-blind, placebo-controlled phase III study involving 549 patients with mid- to late-stage idiopathic PD of more than 3 years’ duration. The patients were treated with stable doses of levodopa and standard of care (i.e., a dopamine agonist, a catechol-O-methyl transferase [COMT] inhibitor, an anticholinergic, and/or amantadine) for at least 4 weeks. Patients who experienced a minimum of 1.5 hours of OFF time during the day were randomly assigned to receive once-daily safinamide (50 to 100 mg) or placebo (standard of care, including levodopa) as adjunctive treatment. The study’s primary endpoint was the change in daily ON time, as assessed by patient-completed daily diary cards (18 hours/day).

Safinamide, an alpha-aminoamide, is being developed as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage PD. The drug is believed to have both dopaminergic and non-dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B) activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.

Source: Newron Pharmaceuticals; June 19, 2013.

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