The FDA recently approved a new extended release oral-suspension therapy, Lumryz (sodium oxybate) from Avadel Pharmaceuticals, for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. Lumryz is taken once daily at bedtime.
Lumryz was approved with a black box warning for Central Nervous System Depression as well as Potential Abuse & Misuse. Lumryz is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and even death. A restrictive REMS has been imposed for the therapy.
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Avadel confirmed that Lumryz will launch at $64.67 per gram. Based on the highest daily dosing option (nine grams), the annual cost would top out at $212,440 per year. This pricing is comparable to that of a competing product, Xywav, from Jazz Pharmaceuticals.
Given its cost and moderately high prevalence of ~140,000 in the USA, is is expected that Lymryz will be available only through specialty pharmacy limited distribution.
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Avadel Pharmaceuticals Announces U.S. Commercial Launch of LUMRYZ (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Adults Living with Narcolepsy
-LUMRYZ is the first and only once-at-bedtime oxybate for people living with narcolepsy
-Once-nightly dosing regimen of LUMRYZ has been found by FDA to provide a major contribution to patient care over all twice-nightly oxybates
DUBLIN, Ireland, June 05, 2023 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZ is now commercially available. LUMRYZ 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.
“We are proud to announce that LUMRYZ is commercially available through both our RYZUP™ patient support program and our specialty pharmacy network for patients living with narcolepsy who have been waiting for over two decades for a single dose treatment option that provides the opportunity for an uninterrupted night sleep,” said Greg Divis, Chief Executive Officer of Avadel. “LUMRYZ represents a new generation of oxybate treatment the FDA deemed clinically superior to all twice nightly oxybate treatments. The Avadel team is fully prepared to execute our commercial strategy and deliver LUMRYZ to the $3 billion plus once-at-bedtime oxybate market.”
LUMRYZ is the first and only U.S. Food & Drug Administration (FDA) approved once-at-bedtime oxybate for people living with narcolepsy. The commercial strategy for LUMRYZ includes an extensive patient support program, RYZUP, which is designed to provide support and education to patients who have been prescribed LUMRYZ and to assist them in gaining access to their medication. More information about the RYZUP patient support program can be accessed at ryzupsupport.com.
LUMRYZ was granted FDA approval based on positive results from the pivotal Phase 3 REST-ON clinical study completed in March 2020. In the REST-ON Phase 3 trial, once-at-bedtime LUMRYZ demonstrated highly statistically significant (p<0.001) and clinically meaningful improvement compared to placebo across all three co-primary endpoints (Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks) for all three doses evaluated, 6, 7.5 and 9 grams.
LUMRYZ was granted a seven year period of Orphan Drug Exclusivity as a result of the FDA finding LUMRYZ to be clinically superior to all first generation oxybate products. In particular, FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. For more information, please visit www.avadel.com.
