drugs to treatment narcolepsy cataplexy and anxiety

An oral presentation demonstrating that treatment with Lumryz at all tested doses in the completed pivotal phase 3 REST-ON clinical resulted in clinically significant improvement in EDS and cataplexy according to American Academy of Sleep Medicine-established criteria.Highlights from the presentations include: Lumryz is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the Lumryz REMS. Lumryz has a boxed warning as a central nervous system depressant and for its potential for abuse and misuse. With final approval of Lumryz, we’re proud to offer the narcolepsy community a once-at-bedtime treatment option for cataplexy or excessive daytime sleepiness that removes the burden of twice-nightly dosing and provides the opportunity for an uninterrupted night’s sleep.” “Additionally, presentations at this year’s conference also include insights gleaned from MyNarcolepsyTeam, where people with narcolepsy reported the need for relief from both daytime and nighttime symptoms. “We are thrilled to attend SLEEP 2023 and present a broad range of data further supporting the clinical value proposition of Lumryz as a once-nightly option to manage EDS and cataplexy in narcolepsy, including data from our RESTORE and REST-ON trials,” says Jennifer Gudeman, PharmD, senior vice president, medical and clinical affairs at Avadel, in a release. Lumryz also was granted Orphan Drug Exclusivity, as the Office of Orphan Product Development identified Lumryz to be clinically superior to immediate-release oxybates based upon the major contribution to patient care that Lumryz provides by way of its once-nightly dosing, according to a release from Avadel.

Lumryz was granted US Food and Drug Administration (FDA) approval in May, and is the first and only FDA-approved once-at-bedtime oxybate for people living with narcolepsy. Lumryz (previously known as FT218), is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. Avadel Pharmaceuticals will present new data supporting the clinical profile for Lumryz (sodium oxybate) for extended-release oral suspension and patient preference for a once-nightly oxybate in 12 abstracts at SLEEP 2023.

Drugs to treatment narcolepsy cataplexy and anxiety