3-D brain wiring illustration (NIH)
30 December 2014. A clinical trial testing a pump worn by Parkinson’s disease patients shows the device can continuously deliver drugs under the skin to treat severe forms of the disorder, which today requires a surgical implant. The pump made by NeuroDerm Ltd. in Rehovot, Israel is designed to overcome shortcomings of oral forms of the drugs levodopa and carbidopa to treat symptoms of Parkinson’s disease.
Parkinson’s disease occurs when the brain produces less and less of the substance dopamine, a neurotransmitter that sends sends signals from one nerve cell to another. As the level of dopamine lowers, individuals become less able to control their bodily movements and emotions. Symptoms include tremors, i.e. shaking, slowness and rigidity in movements, loss of facial expression, decreased ability to control blinking and swallowing, and in some cases, depression and anxiety. According to National Parkinson Foundation, some 50,000 to 60,000 new cases of Parkinson’s disease are diagnosed each year.
Among treatments for Parkinson’s symptoms is levodopa, a nervous system agent that converts to dopamine in the brain. Levodopa is often given with carbidopa that gives levodopa more stability and prevents it from breaking down before it reaches the brain, allowing for lower doses. The lower doses of levodopa help reduce nausea sometimes caused by the drug.
Even with carbidopa, however, levodopa taken as a pill still has a short activity life and low absorption, which requires patients to take the drug every 3 to 4 hours, and with only about 30 percent entering the blood stream. To deliver levodopa and carbidopa continuously today, for some patients with severe forms of Parkinson’s disease, requires a pump that infuses the drugs in gel form directly into the small intestine with a tube that must be surgically implanted.
The device developed by NeuroDerm aims to provide continuous delivery of levodopa and carbidopa without surgery. The device code-named ND0612 is a small pump worn on the belt, with 1 or 2 tubes inserted under the skin to deliver a liquid form of the drugs. The ND0612H version is designed to deliver higher doses of the levodopa and carbidopa with 2 tubes, while ND0612L delivers lower doses using 1 tube.
The intermediate-stage clinical trial tested the safety and tolerability of the pump device with a small sample of Parkinson’s disease patients, against a placebo and earlier baseline readings for oral forms of the drugs. The trial also tested the ability of the device to deliver the drugs in maximum concentrations sufficient to treat Parkinson’s symptoms. Of the patients in the trial, 7 were fitted with the higher-dose pump, while 9 had the lower-dose version, with the drugs administered for 8 hours a day over 3 days. All of the patients also took entacapone, an oral drug that helps extend the effects of levodopa and carbidopa.
The results reported by the company show the NeuroDerm devices delivered higher and lower doses of levodopa and carbidopa, as designed, over the treatment periods. In addition, says the company, the devices markedly reduced fluctuations in levodopa and carbidopa levels in the patients’ blood streams, compared to earlier baseline levels for oral forms of the drugs. The company reports as well that all patients completed the trial, with the only adverse effects being minor reactions at the infusion sites.
Oded Lieberman, NeuroDerm’s CEO, says in a company statement that based on the results, “we will proceed with the clinical development of ND0612H and ND0612L in the United States and the European Union in 2015.”
Read more:
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- Daiichi Sankyo, UCSF Partner on Neurodegenerative Disorders
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