LUMRYZ is an extended-release formulation of sodium oxybate, indicated to be taken once at bedtime.
The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023.
The regulatory approval was based on the findings from the pivotal Phase III REST-ON clinical trial completed in March 2020.
Once-at-bedtime LUMRYZ showed highly statistically significant and clinically meaningful improvement across all three co-primary endpoints for all three doses assessed in the trial compared with placebo.
The company’s commercial strategy for the therapy includes an extensive patient support programme named RYZUP, which supports and educates those for whom the drug is prescribed and assists with access to the medicine.
Avadel Pharmaceuticals CEO Greg Divis stated: “We are proud to announce that LUMRYZ is commercially available through both our RYZUP patient support programme and our speciality 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’s sleep.
“LUMRYZ represents a new generation of oxybate treatment that the FDA deems clinically superior to twice-nightly oxybate treatments.
“The Avadel team is fully prepared to execute our commercial strategy and deliver LUMRYZ to the $3bn-plus once-at-bedtime oxybate market.”