Newron Pharmaceuticals and Zambon have entered into an agreement that has the potential to produce a label extension for a treatment for Parkinson’s. The agreement is focused on safinamide as a therapy for levodopa induced dyskinesia (LID) in those with Parkinson’s disease. If all goes according to plan, the companies will work together on a clinical trial which would hopefully result in a label extension of safinamide.
Terms of the Agreement
Both companies are assigned different responsibilities under the terms of their agreement. Newron will be in charge of and sponsor the trial, giving them the responsibility of development and execution of the study. They will also take charge when it comes to regulatory interactions, such as meetings with the FDA. The two companies will share the cost of the trial evenly.
About the Study
This trial will be placebo-controlled, double-blind, and run throughout the United States, Asia, Australia, and Europe. Researchers intend to achieve a label extension for safinamide, as it has already been approved as an add-on to levodopa for Parkinson’s patients.
About Parkinson’s Disease
Parkinson’s disease is a progressive disorder that affects the central nervous system (CNS). It is characterized by its effect on movement through five different stages. As the disease progresses, severity increases. Stage one is characterized by subtle tremors on one side of the body. In stage two symptoms are more noticeable, with tremors and rigidity on both sides of the body. Stage three brings loss of balance and slowed movement. Stage four makes it impossible for one to live independently. Stage five is the most severe, as patients cannot stand or walk. Hallucinations and delusions are common symptoms of this stage.
Parkinson’s disease occurs due to the death of motor neurons, some of which produce dopamine. Dopamine is important in the transmittance of messages to the muscles from the brain, so the loss of dopamine results in the loss of motor functions. Abnormal brain activity occurs when these neurons are lost. Doctors do not know why these motor neurons die, but they do suspect a few factors that play a role, such as genetics, environmental factors like toxins, and Lewy bodies.
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