Approval of new drug for Parkinson’s disease by USFDA
March 21, 2017
USFDA has approved a new drug for patients with Parkinson’s disease who are currently taking levodopa / carbidopa and experiencing “off” episodes. Parkinson’s disease is a disorder of the central nervous system that affects movement, often including tremors. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking.
USFDA has approved Safinamide drug as replacement for carbidopa / levodopa. Eric Bastings, M.D., deputy director of the Division of Neurology Products, FDA said “Parkinson’s is a relentless disease without a cure”. According to National Institutes of Health every year around 50,000 peoples are diagnosed with Parkinson’s disease. The disease prone to occur in people over age 60, although it can also occur earlier when production of dopamine is impaired of dead.
The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others.
The efficacy of Safinamide in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Safinamide experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.
In another clinical trial of 549 participants, the participants adding Safinamide to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.
The most common adverse reactions observed in patients taking Safinamide were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).
The FDA has granted approval of Safinamide to Newron Pharmaceuticals