6/8/2023 0 Comments Narcolepsy cataplexy"Lumryz can now offer people with narcolepsy the opportunity for an uninterrupted night sleep while receiving the full benefit of their prescribed treatment in one single bedtime dose that addresses their symptoms of narcolepsy."Īpproval of Lumryz was granted to Avadel. These episodes vary in frequency from a few incidents to several during a single day. Attacks of drowsiness may persist for only a few seconds or several minutes. As we have heard from key stakeholders, previously approved narcolepsy therapies have the potential to disrupt sleep by either causing insomnia or through forced awakening during the middle of the night for their crucial second dose," Greg Divis, CEO of Avadel Pharmaceuticals, said in a statement. Narcolepsy is a neurological sleep disorder characterized by chronic, excessive attacks of drowsiness during the day, sometimes called excessive daytime sleepiness (EDS). "Today's landmark approval and receipt of Orphan Drug Exclusivity represents a major milestone for both Avadel and people living with narcolepsy. The most common adverse reactions (incidence of more than 5 percent and greater than placebo) were nausea, dizziness, enuresis, headache, and vomiting, which were reported for all doses. Most affected individuals have trouble sleeping for more than a few hours at night. However, some do not, which has led researchers to distinguish two major forms of the condition: narcolepsy with cataplexy and narcolepsy without cataplexy. Some people can mistake this for fainting or seizure activity. Most people diagnosed with narcolepsy also have cataplexy. The approval was based on results from the REST-ON phase 3 trial, in which once-at-bedtime Lumryz led to significant and clinically meaningful improvement across the three coprimary end points of Maintenance of Wakefulness Test, Clinical Global Impression-Improvement, and mean weekly cataplexy attacks versus placebo for all three doses evaluated. Narcolepsy may also involve unexpected loss of muscle control, known as cataplexy.
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