Solriamfetol PDUFA Date Pushed, Recognizing Parkinson Disease, Chronic Migraine Peer Exchange Program
Neurology News Network for the week of January 5, 2019.
PUBLISHED January 05, 2019
This week, Neurology News Network covered the FDA's decision to delay the review of solriamfetol's New Drug Application, as well as a conversation with the director of clinical trials at the University of Florida’s Center for Movement Disorders and Neurorestoration about the need for better early recognition of Parkinson disease. Additionally, the network included the premiere of the tenth episode of NeurologyLive's latest Peer Exchange. (Transcript below.)
Welcome to Neurology News Network. I’m Matt Hoffman. Let’s get into the news from this week.
Just before the new year, the FDA decided to push back the PDUFA date for solriamfetol, an investigational agent for the improvement of wakefulness and reduction of excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea. The date has been moved 3 months, to March 20.
According to manufacturer Jazz Pharmaceuticals, during the discussions surrounding the draft labeling, the FDA determined that the submission constitutes “a major amendment” to the NDA. In order to provide adequate time for a full review of this submission, the agency has chosen to extend the PDUFA date.
And while early detection is incredibly important, developing better therapies and add-on treatments to address the wearing off of levodopa is another essential area of concern for Ramirez-Zamora. He told NeurologyLive that “a big message should be that Parkinson disease is not only a problem with dopamine. Other neurotransmitters are affected. Serotonin and norepinephrine, they're also affected, and they may actually cause some of the most debilitating symptoms later in the disease.”
Episode 10 of NeurologyLive’s latest Peer Exchange, “Chronic Migraine New Paradigms in Management,” has premiered! In this episode, several migraine experts review the favorable safety data for the recently approved monoclonal antibodies targeting calcitonin gene-related peptide.
Let’s take a look.
For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.