Sleeping Pills and Increased Mortality, IPX203 Receives CRL, CT1812 Impacts Brain Function


Neurology News Network for the week ending July 8, 2023. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Data from a nationwide study of nearly 500,000 adults in Taiwan identified an association between sleeping pills and an increased risk of mortality and shortened life expectancy, especially in extreme sleepers. Investigators concluded that strategies to raise public and clinician awareness of the potential harms are needed, considering the increasing trends in long-term hypnotic/sedative prescriptions worldwide. The study featured 484,916 community-dwelling adults in Taiwan who were categorized by daily sleep duration into 4 groups: extremely short (<4 h), short (4-6 h), medium (6-8 h), and long (>8 h). With 6-8 hours of daily sleep, sleeping pill nonusers had the lowest mortality risk. Sleeping pill users, even with this optimal amount of sleep, had a 55% higher mortality risk than nonusers.

The FDA has issued a complete response letter (CRL) to Amneal Pharmaceuticals for IPX203, an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules designed for the treatment of Parkinson’s disease. Reasons behind the decision were not based on efficacy or manufacturing for the agent, but rather established safety for an ingredient of the therapy. In its release, the agency noted that the pharmcokinectic data for the safety of one ingredient, levodopa, was sufficient; however, it felt it needed additional data for the second ingredient, carbidopa. Amneal plans to work closely with the FDA to address the comments and align on the best path forward. The supporting data for IPX203's new drug application (NDA) submission came from the phase 3 RISE-PD clinical trial which consisted of a 3-week, open-label dose adjustment phase. The trial was followed by a 4-week open-label conversion to IPX203 and a 13-week double blind maintenance phase.

Recently announced topline findings from the phase 2 SEQUEL study showed that CT1812, an investigational agent, met its primary end points for safety and tolerability, with positive, non-statistically significant impacts observed in underlying brain function. Full analyses of the results from SEQUEL, along with analyses of Alzheimer disease (AD) canonical biomarkers and proteomics from participants in the study, will be presented at an upcoming medical meeting. Supported by a grant from the National Institute on Aging, SEQUEL was designed to assess differences in synaptic function in CT1812-treated patients vs placebo using quantitative EEG. The single-site, randomized, double-blind, placebo-controlled, 29-day, 2-period crossover study featured 16 individuals with mild to moderate AD. Patients who received active treatment in period 1 received placebo in period 2, and vice versa.

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