Siponimod Approved for SPMS, AVP-786 Phase 3 Results for Treatment of Agitation in Alzheimer-Related Dementia, and Mobile Technology for Care of Parkinson Disease
Neurology News Network for the week of March 30, 2019.
PUBLISHED March 30, 2019
This week, Neurology News Network covered the FDA approval of siponimod for treatment of active secondary progressive MS, the topline results from TRIAD-1 investigational AVP-786 for treatment of moderate-to-severe agitation in Alzheimer-related dementia, and how the development and implementation of mobile health technology into routine use in care of Parkinson disease is now necessary. (Transcript below)
Welcome to Neurology News Network. I’m Jenna Payesko.Let’s get into the news from this week.
The FDA approved siponimod, marketed as Mayzent by Novartis, as the first treatment for patients with active secondary progressive MS in more than a decade. The approval was granted based on data from the EXPAND trial, which ultimately showed that 3-month confirmed disability progression was reduced by 21% with the agent.
Paul Hudson, the chief executive officer of Novartis, said in a statement that with Mayzent, “SPMS patients with active disease will have access to the first effective oral therapy directed towards disease progression, even when MS transitions to a stage where deterioration is less dependent on the usual relapse activity.”
Avanir Pharmaceuticals released topline results from TRIAD-1, a phase 3 study of the investigational therapy AVP-786 for the treatment of moderate-to-severe agitation in patients with Alzheimer-related dementia. Results demonstrated a significant improvement on the primary endpoint, the change in the Cohen-Mansfield Agitation Inventory, for 1 of the 2 doses being studied.
Improvements were observed for both doses from baseline to week 12, though the change in Cohen-Mansfield Agitation Inventory was only statistically significant for one. Similar improvements were reported on the key secondary endpoint, as well.
The Task Force wrote that “the improvements in the sophistication, versatility, and wearability of these technologies have reached a state of maturity that is adequate for the collection of patient-relevant data. They had 4 recommendations for the process: the tech should target patient deficits, achieve acceptable benefit-to-burden ratios, should be standardized and individualized, and should be approved and integrated intohealthy systems.
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