Safinamide May Reduce Involuntary Movements in Parkinsons Disease
An experimental new drug developed by Newron Pharmaceuticals may help to reduced dyskinesia (involuntary movements) in mid-to-late stage Parkinson’s disease (PD) per new findings from a clinical study presented at the 63rd Annual Meeting of the American Academy of Neurology.
Safinamide at Higher Dose Helped One-Third of Severely Affected Patients
Safinamide, currently in phase III clinical trials, is a unique molecule with multiple mechanisms of action. It combines selective and reversible inhibition of MAO-B, an enzyme that degrades dopamine, with blockage of sodium and calcium channels and inhibition of glutamate release. Previous research from the University of California, Los Angeles, School of Public Health found that the use of calcium channel blockers, specifically dihydropyridines, may protect against the development of PD.
MAO-B-inhibiting drugs also slow the breakdown of dopamine in the brain. The three formulations already approved for use in Parkinson’s disease patients are Rasagiline (Azilect), Selegiline swallowed tablets (Eldepryl), and Selegiline orally dissolving tablets (Zelapar).
Study author Ravi Anand MD, a consultant with Newron, studied 669 patients with mid-to-late stage Parkinson’s disease who were already taking levodopa, which increases dopamine concentrations. PD is caused when the brain cells that make this brain chemical are slowly destroyed. Participants were given either 50 to 100 milligrams of safinamide per day or a placebo. The researchers tested movement ability using the United Parkinson’s disease rating scale that measures tremor, speech, behavior, mood and daily activities such as dressing.
After two years, the researchers discovered that those taking 100 mg of safinamide in addition to levodopa reduced dyskinesia by 24% in the one-third of participants who had scored a four or higher on the dyskinesia rating scale. The higher score indicates greater severity of symptoms. There were no significant differences in the patients taking the 50 mg dose versus a placebo.
“Our findings over a two-year treatment period suggest that taking safinamide in addition to levodopa and other dopaminergic treatments could help patients who continue to experience tremors and involuntary movement problems,” said Dr. Anand. “These results are an important step forward in understanding how safinamide impacts patients with severe Parkinson’s disease. Symptoms of Parkinson`s disease, motor fluctuations and dyskinesia can greatly affect a person’s daily living and quality of life.”
Anand R, et al "First long-term (2-year) controlled study to evaluate treatment with safinamide as add-on to levodopa in patients with Parkinson's disease and motor fluctuations" AAN 2011; Abstract P05.287.