New data suggest that brain changes in the posterior cingulate cortex and precuneus as a result of SDB may increase the risk of Alzheimer disease, supporting prior findings which imply a link between the conditions.
Researchers noted at least a 50% reduction from baseline in mean number of moderate to severe migraine days per month in 48% of the rimegepant group.
The agency has assigned a PDUFA date of July 31, 2020, for the purified CBD treatment which has been previously approved for Dravet and Lennox-Gastaut syndromes.
Nearly all patients in this cohort achieved a clinically meaningful >3-point increase during the study period, demonstrating a consistent response to the gene therapy.
Catabasis’s small molecule NF-kB inhibitor showed promise in phase 2, and the phase 3 PolarisDMD study (NCT03703882) of edasalonexant is fully enrolled and expected to read out in late 2020.
Although the drug requires no CYP2C9 genotyping or first-dose observation, an up-titration scheme should be used due to the risk of transient cardiac conduction issues.
SK Life Science’s newly approved treatment for partial-onset seizures is set to launch in the second quarter of 2020, after being designated Schedule V by the DEA.
The report suggests with moderate certainty that all 3 therapies offer a small or substantial net health benefit and with a high certainty of at least a small net health benefit.
Disease-modifying therapies used to treat several immune-mediated disorders in neurology may make patients more susceptible to the novel coronavirus.
The drug was previously approved for the treatment of acute repetitive seizures and granted 7 years of orphan drug exclusivity in January 2020.