Neurocrine Biosciences files NDA for opicapone for Parkinson’s disease

Neurocrine Biosciences announced that the US FDA has provided assistance on the regulatory path forward to support the New Drug Application for opicapone, an investigational drug for Parkinson’s disease, after receiving meeting minutes from the January 2018 meeting with the FDA.

It is to be noted that Parkinson’s disease is a chronic and progressive movement disorder that affects approximately one million people in the United States. The disease is characterized by a loss of neurons in the substantia nigra, the area of the brain where dopamine is produced. Dopamine production and synthesis is necessary for coordination and movement.

Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine claimed “We have a tremendous amount of work ahead of us as we compile the FDA-required datasets to prepare for the NDA filing, which we plan to have completed during the first half of 2019. As part of our commitment to helping patients with movement disorders, we are eager to continue advancing this important medicine for the nearly one million patients suffering from Parkinson’s disease in the United States.”

Opicapone, an investigational drug in the U.S., is a once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase (COMT) inhibitor being developed as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors for adult patients with Parkinson’s disease and motor fluctuations.