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ONCE AT BEDTIME
FOR THEIR DAYTIME1

LUMRYZ is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.1

Major Contribution to Patient Care2 - FDA, May 2023

FDA has determined LUMRYZ to be clinically superior* to twice-nightly oxybates2

LUMRYZ once-at-bedtime dosing was granted Orphan Drug Exclusivity (ODE) status by the FDA on May 1, 2023, which determined it to be clinically superior to both XYREM® and XYWAV® twice-nightly oxybates on the basis of being a major contribution to patient care.3

See FDA findings on major contribution to patient care*
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*Based on a determination of ODE by the FDA Office of Orphan Products Development between LUMRYZ and XYREM or XYWAV. There are no head-to-head data for LUMRYZ and XYREM or XYWAV.

LUMRYZ is once at bedtime, for their daytime1

The first and only single-dose sodium oxybate to help provide daytime symptom control of EDS and cataplexy.1

Established safety and demonstrated efficacy across 3 co-primary endpoints (MWT, CGI-I, weekly cataplexy attacks) and select secondary endpoint (ESS)4 Explore efficacy
Delivers treatment throughout the course of a nocturnal sleep period1,4,5 See how it works
Premeasured packets contain a full therapeutic dose1 Discover once-at-
bedtime dosing
RYZUP Support Services dedicated to helping your patients and your office Getting your patients started

Help improve their daytime symptoms with a single-dose sodium oxybate.1

Start on or switch your patients to the appropriate dose of LUMRYZ.

Start or switch

Are you REMS-certified?

As with other sodium-oxybate treatments, you must be Risk Evaluation and Mitigation Strategy (REMS) certified in order to prescribe LUMRYZ.

Ready to start patients on LUMRYZ?

Enrolling patients in the LUMRYZ REMS and RYZUP Support Services is required to ensure your patients receive LUMRYZ as prescribed. What to expect
when getting started

CGI-I, Clinical Global Impression-Improvement; ESS, Epworth Sleepiness Scale; MWT, Maintenance of Wakefulness Test.

References:

  1. References: 1. LUMRYZ (sodium oxybate for extended-release oral suspension). Prescribing Information. Chesterfield, MO: Avadel Pharmaceuticals. 2. US Food and Drug Administration. Clinical superiority findings. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings#644fe8ebd4a58 3. Office of Orphan Products Development Food and Drug Administration. Re: Determination that Xywav’s (NDA 212690) unexpired orphan-drug exclusivity (“ODE”) does not block approval of Lumryz (NDA 214755). Silver Spring, MD; May 1, 2023. 1-132. 4. Kushida CA, Shapiro CM, Roth T, et al. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022;45(6):1-11. doi:10.1093/sleep/zsab200 5. Bogan R, Thorpy MJ, Winkelman JW, et al. Randomized, crossover, open-label study of the relative bioavailability and safety of FT218, a once-nightly sodium oxybate formulation: phase 1 study in healthy volunteers. Sleep Med. 2022;100:442-447.