Avadel Pharmaceuticals reported in its fourth-quarter and full-year 2023 update that Lumryz, the company’s novel narcolepsy medication for once-at-bedtime use, has been initiated by over 1,200 patients since its June launch.
The company further detailed that its RYZUP patient support services have seen over 2,200 enrollments, with the majority of enrollments and patients currently being treated with Lumryz being patients who switched from first-generation oxybates. The balance is made up of patients who previously tried and discontinued a first-generation oxybate and patients who are new to oxybate treatment.
“We are carrying significant momentum into 2024 following the successful launch of Lumryz and are pleased with the strong early launch results we have seen. We have established a strong foundation with patients, prescribers, and payers to build on and advance our mission of transforming the lives of people living with narcolepsy,” says Greg Divis, chief executive officer of Avadel Pharmaceuticals, in a release. “While the launch is still in the early stages, we believe the meaningful increase in patients initiating therapy with Lumryz underscores the significant unmet need for a once-at-bedtime therapy.”
Additionally, Avadel secured payor coverage policies for greater than 80% of commercially covered lives with the inclusion of Anthem and the United Healthcare national formulary. Contracts are now established with all three pharmacy benefit managers-owned group purchasing organizations (Ascent/ESI, Zinc/CVS, and Emisar/Optum).
Approximately 1,900 health care providers have completed the LUMRYZ Risk Evaluation and Mitigation Strategy certification process, including both experienced oxybate prescribers as well as providers who have never previously prescribed an oxybate.
As for pipeline updates, Avadel announced the US Food and Drug Administration (FDA) accepted the Supplemental New Drug Application for Lumryz for the treatment of cataplexy or excessive daytime sleepiness in the pediatric narcolepsy population. The FDA has assigned a target action date of Sept 7 for its approval decision.
With potential approval in the pediatric population, Lumryz could alleviate the burden placed on families and caregivers of children with narcolepsy who are responsible for waking up in the middle of the night to administer a second dose, according to a release from Avadel. Pediatric patients currently represent approximately 3-5% of all oxybate-treated narcolepsy patients.
Further, Avadel is planning to enroll the first patient in a clinical study for the use of Lumryz to treat idiopathic hypersomnia in the second half of 2024.
