FDA to Review Once-Nightly Sodium Oxybate Formulation for Narcolepsy
The NDA submission is supported by data from the phase 3 REST-ON study.
Sleep Disorders
Exhalation Delivery System With Fluticasone Improves Sleep in Nasal Polyposis
In patients with moderate to severe chronic rhinosinusitis with nasal polyposis, treatment with an Exhalation Delivery System With Fluticasone (EDS-FLU) is associated with improved sleep scores.
Omalizumab May Be Associated With Improved Sleep Outcomes in CRSwNP
Treatment with omalizumab was associated with sleep improvements in patients with chronic rhinosinusitis with nasal polyps.
MPR Weekly Dose Podcast Episode 68
This week we cover a caution about remdesivir; New and updated Emergency Use Authorizations; And new approvals in sleep apnea and for Botox.
Novel Rx Device for Sleep Apnea, Snoring Gets FDA Approval
The eXciteOSA device is used while the individual is awake and provides electrical muscle stimulation through a mouthpiece that sits around the tongue.
MPR Weekly Dose Podcast Episode 60
This week the FDA and the WHO have a back and forth over remdesivir; Who should get a COVID vaccine; Xolair and Hetlioz have approval expansions; And a novel neuroblastoma treatment gets accelerated approval.
Hetlioz Approved for Nighttime Sleep Disturbances in Smith-Magenis Syndrome
The approval was based on data from a 9-week, double-blind, placebo-controlled, crossover study which assessed the effects of Hetlioz in patients with SMS.
FDA Authorizes Digital Therapeutic for Sleep Disturbance in PTSD
NightWare is a smartwatch application that uses the Apple Watch and Apple iPhone platform.
Valerian Quality, Storage Issues May Affect Sleep Outcomes
While valerian is considered a popular herbal supplement for managing sleep disorders, study outcomes related to its effectiveness have been inconsistent.
Wakix Indication Expanded to Include Cataplexy Treatment
The approval was based on data from two phase 3 trials (HARMONY CTP and HARMONY 1) that evaluated the efficacy and safety of pitolisant for the treatment of cataplexy.
