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One of the most well-known sufferers of the debilitating neurological disease known as Parkinson’s is Hollywood actor Michael J Fox. Fox has set up a foundation dedicated to finding a cure for the disorder that causes uncontrolled shaking and difficulty walking. Now a new drug is looking good in a mid-stage study, as an alternative to surgery to improve symptoms. MS
Reuters – A higher dose of a Parkinson’s drug could provide an alternative to treatments that require surgery, according to a mid-stage study, says Israel-based NeuroDerm.
The company’s shares have more than doubled in value, after announcement of data from the study on its drug.
The trial evaluated two liquid formulations of the drug, levodopa/carbidopa (LD/CD), in 16 patients with an advanced form of the disease to assess its capacity to reduce Parkinson’s-related motor complications, the Israel-based company said.
Delivered through a belt-worn pump, the two versions of the drug, ND0612H and ND0612L, were compared with oral forms of LD/CD, the standard of care for Parkinson’s. Data showed that ND0612H achieved levodopa plasma levels that could only be maintained through surgical intervention and that fluctuations in levodopa plasma levels were markedly reduced by both versions, the company said.
Nearly all patients diagnosed with Parkinson’s, characterised by reduced dopamine levels in the brain, are treated with levodopa. The effectiveness of oral levodopa is limited by its short half-life. The drug remains in the plasma for only up to four hours following a single dose, requiring patients to take multiple doses daily to fight periods of decline in motor and non-motor function.
Excessive/intermittent oral doses of levodopa often leads to involuntary movements, or dyskinesia, in some patients. Currently, steady levodopa administration can only be achieved through permanent implantation of a tube in the small intestine.
The US regulatory body, the Food and Drug Administration (FDA) is set to decide on other levodopa formulations such as Rytary developed by Impax Laboratories Inc and Duodopa from Abbvie Inc in 2015.
Jefferies & Co analyst Thomas Wei said he expected NeuroDerm’s offerings to demonstrate greater benefits in effectiveness and safety relative to Rytary. Wei also said ND0612H would likely offer more convenience than Duodopa, with a more benign safety profile.
NeuroDerm said the data allows for further development of ND0612H and ND0612L in the United States and the European Union in 2015.
About one million Americans live with Parkinson’s, more than the combined number of people diagnosed with multiple sclerosis, muscular dystrophy and Lou Gehrig’s disease, according to the Parkinson’s Disease Foundation.
NeuroDerm is testing two other Parkinson’s drugs. Its pipeline also consists of another drug being evaluated for use in ADD/ADHD, Alzheimer’s and schizophrenia.
Shares of the company, which went public on November 14, was up 118% in December at $13.49, crossing their IPO price of $10 for the first time. – Reuters
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