Lumryz is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in children ...
The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...
Lumryz is an extended-release formulation of sodium oxybate, a central nervous system (CNS) depressant. Its therapeutic effects are believed to be mediated through GABA B actions at noradrenergic and ...
Avadel's drug contains a central nervous system depressant drug called sodium oxybate, which helps increase the amount of ...
in patients 7 years of age and older with narcolepsy. Previously the treatment had only been approved for adults. Lumryz is an extended-release formulation of sodium oxybate, a central nervous ...
Along with the approval, the FDA also granted seven years of orphan drug exclusivity to Lumryz for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical ...
Shares of Jazz Pharmaceuticals are trading only slightly higher in the last few weeks despite two unexpected wins. Explore ...
Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...
Avadel Pharmaceuticals has won expanded Food and Drug Administration approval of its narcolepsy drug Lumryz for use in children. Avadel on Thursday said the FDA nod covers Lumryz for the treatment of ...