FDA Approves Lumryz for Treatment of Narcolepsy

Описание: Anne Marie Morse, DO, of Geisinger Health, discusses the U.S. Food and Drug Administration (FDA) approval of Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy ages 7 years and older.

Narcolepsy is a rare, chronic, neurological disorder affecting the brain’s ability to control sleep-wake cycles. Common symptoms include excessive daytime sleepiness (EDS), cataplexy, sleep paralysis, hallucinations, and fragmented sleep and insomnia. These symptoms can greatly affect daily activities and may partially improve over time but will never go completely away.

As Dr. Morse explains, in a normal sleep cycle, a person enters rapid eye movement (REM) sleep after about 60 to 90 minutes. People with narcolepsy frequently enter REM sleep rapidly, within 15 minutes of falling asleep. Also, the muscle weakness or dream activity of REM sleep can occur during wakefulness or be absent during sleep.

Lumryz is an FDA approved extended-release sodium oxybate and the only once-at-bedtime treatment for narcolepsy in those ages 7 years and older. The approval follows results from the REST-ON clinical trial, a phase 3, randomized, double-blind, placebo-controlled study in adults with narcolepsy. In this study, statistically significant and clinically meaningful improvements were observed in the three primary endpoints when compared to placebo. These endpoints included EDS, clinicians’ assessment of patient functioning, and cataplexy attacks.