Clinical Trials Begin for Novel Administration of Levodopa in Advanced PD
The Israeli pharmaceutical company, NeuroDerm Ltd., has begun clinical trials in human subjects with advanced stages of PARKINSON’S DISEASE who are unable to tolerate oral types of levodopa/carbidopa medications. They expect to have completed the first stage by the end of this year and will make their data public.
As PARKINSON’S DISEASE progresses and patients age, they become less able to tolerate the motor and non-motor fluctuations caused by absorption problems with orally administered levodopa/carbidopa. In advanced stages, oral levodopa no longer seems to be effective, and patients must decide between considering deep brain stimulation or the surgical insertion of an intra-duodenal levodopa/carbidopa pump. Both surgeries are invasive and subject to serious complications and for some people, neither feasible nor desirable.
NeuroDerm has developed a proprietary formulation of liquid levodopa/carbidopa, which they are able to deliver in a continuous dose subcutaneously with a patch and a pump worn on the belt. Delivering a continuous dose of levodopa/carbidopa will eliminate the uneven responses that come from scheduled doses not uniformly absorbed through the digestive tract. Using a pump to deliver a continuous, uniform dose directly under the skin both day and night should improve the effectiveness of levodopa/carbidopa and reduce motor complications and make life easier for people with PARKINSON’S DISEASE.
The present trial is designed to evaluate the response of people with advanced stages of PARKINSON’S DISEASE to various dosage strengths of NeuroDerm’s liquid formula levodopa/carbidopa. Safety and tolerability have already been established, this study will measure drug concentrations in blood levels and motor responses to the doses.
The company has also prepared a low-dose form of liquid levodopa/carbidopa for people with moderate stages of PARKINSON’S DISEASE. A Phase II double blind, randomized, placebo-controlled trial has just finished enrolling all the subjects and completed their treatment. The data is presently being analyzed and the results will soon be made available.
NeuroDerm is a company focused on developing and providing enhanced treatments for major neurodegenerative diseases that will overcome problems encountered with traditional therapies. All of their products are designed to be delivered in a continuous, steady dose delivered subcutaneously by a small pump worn on a belt. They have developed three types of liquid levodopa/carbidopa for patients with moderate to advanced stages of PARKINSON’S and another for an even more severe stage. They are currently developing a formula for liquid apomorphine for patients with severe stages of PARKINSON’S who do not respond to levodopa.
Information provided by NeuroDerm LLC, Rohovot, Israel
Reviewed by Marcia McCall