Investigators sought to determine whether baclofen might be an effective treatment for excessive daytime sleepiness and sleep fragmentation in patients with narcolepsy.
The NDA includes data from two Phase 3 clinical trials (SUNRISE 1 and SUNRISE 2) which included approximately 2000 patients.
Among patients with obstructive sleep apnea, older age and reduced BMI are predictors of upper airway stimulation treatment response.
Rapid eye movement sleep behavior disorder is more common among men, as well as those with psychological distress, mental illness, or PTSD.
In the Phase 3 JET8 study (N=318), patients underwent a circadian challenge of 8 hours in advance to their usual bedtime.
Solriamfetol therapy, compared with placebo, results in improvements in wakefulness and sleepiness measures in patients with excessive sleepiness due to obstructive sleep apnea.
Efficacy in the pediatric population with narcolepsy was demonstrated in the Phase 2/3 EXPRESS study (N=106) which included patients aged 7 to 17 years with narcolepsy with cataplexy.
The Company stated that they plan to begin a Phase 2 trial of AXS-12 before the end of 2018, with results anticipated for the first half of 2019.
For individuals with obstructive sleep apnea, those with short respiratory event duration have an increased risk for mortality.
The investigators found a significant reduction in the mean preimplantation apnea-hypopnea index at 6 months after hypoglossal nerve stimulation.