FDA approves "first-in-class" innovative therapy to treat excessive drowsiness in the day

Seizure apsydal sleep ingestis is a rare neurological disease in which patients experience drowsiness symptoms due to their inability to regulate the cycle of sleep and wakefulnessThe two main symptoms are excessive daytime drowsiness (EDS) or repeated out-of-control sleep seizures during normal waking, and sudden onset of muscle weakness (sudden fall)EDS is a symptom of not being able to stay awake and alert during the day and is a symptom that occurs in all people with narcolepsyIn most narcolepsy is caused by the absence of hypohypohocy (hypocretin), a neuropeptide in the brain that supports a stable sleep-wake statethe approval was based on two multicenter, randomized, double-blind, placebo-controlled studies (HARMONY 1 and HARMONY 1bis) to evaluate the efficacy of Wakix in treating EDS in adult seizure patientsThe study included 261 patients in a group who were randomly accepted wakix, placebo, or positive control drugs, with median ages of 37 (HARMONY 1) and 40 years (HARMONY 1bis) for eight weeksBetween 75% and 80% of patients have a history of sudden fallsIn both studies, Wakix demonstrated a statistically significant improvement in EDS by measuring the ESS scoreWakix was developed by Bioprojet and was approved for listing in Europe in 2016Harmony has the exclusive license of Bioprojet to develop, produce and commercialize the drug in the United StatesWakix was granted an FDA-approved prescription in 2010 for the treatment of onset sleeping sicknessin March, the FDA also approved another narcolepsy treatment, solriamfetol, to treat excessive daytime drowsiness associated with narcolepsy or obstructive sleep apnea (OSA) syndromeReferences:, Harmony Biosciences Announces FDA Approval Of WAKIX ® , A First-In-Class Medication For The Treatment Of Ever-DayTime Sleepiness Adult Patients WithColeNarsyRetrieved 2019-08-15, from https://original title: Express , Treatment of Over-Sleeping, FDA Approves "first-in-class" innovative therapy