New Parkinson’s Drug Formulation Shows Positive Phase III Trial Results
Tuesday, 17th January 2023

Another new medication for Parkinson’s may soon be on its way to the U.S. Food and Drug Administration (FDA) for possible approval.

Neuroderm recently announced positive results from its Phase III trial on ND0612, a liquid levodopa/carbidopa. Levodopa temporarily replaces the dopamine brain chemical, which decreases in Parkinson’s, to ease motor symptoms, like tremor, slowness and stiffness. It’s currently available as a pill (to take by mouth), inhaler or gel (for infusion into the small intestine).

ND0612 is a liquid that’s infused continuously, under the skin. Like the available gel and inhaled formulations of levodopa, this drug bypasses the stomach, which can empty slowly or irregularly in Parkinson’s, interfering with medication absorption.  The 24-hour-a-day infusion aims to provide consistent medication levels for consistent symptom relief. This may be particularly beneficial for people who experience ups and downs in symptom control throughout the day — motor fluctuations — which cannot be adequately controlled with oral medications. Motor fluctuations can happen after living with Parkinson’s and taking medication for many years.

In a Phase III trial, researchers randomly assigned people with Parkinson’s to take either levodopa/carbidopa pills or ND0612 for 12 weeks. Those on ND0612 had nearly one and three-quarters hours more “on” time per day, without significant symptoms, like tremor, slowness or stiffness or dyskinesia (involuntary movement). The most common potential side effects included infusion site reactions, like bruising, swelling and bleeding.

The Michael J. Fox Foundation funded earlier studies of this therapy, a critical step toward gathering additional data, support and momentum on the path to this current late stage of drug development.

The next step on the path to potential approval is for the company to submit an application to the FDA. If approved, this therapy would offer another treatment option for people with progressing Parkinson’s who are unable to achieve optimal symptom control with oral medications.

Stay tuned for updates on this and other new potential medications in the pipeline.

Article Source: The Michael J. Fox for Parkinson’s Research