Avadel Pharmaceuticals plc shared updates on the performance and reception of its new narcolepsy medication, Lumryz, a once-at-bedtime extended-release sodium oxybate medication that has been on the market since June 2023.

Since its launch, Lumryz has been prescribed to over 1,000 patients, with more than 1,900 patients enrolled in Avadel’s RYZUP patient support services. The majority of RYZUP enrollments and patients currently being treated with Lumryz are patients who switched from first-generation oxybates, with the balance made up of patients who previously tried and discontinued a first-generation oxybate and patients who are new to oxybate treatment, according to a release from Avadel.

In terms of healthcare provider engagement, nearly 1,800 providers have completed the Lumryz Risk Evaluation and Mitigation Strategy (REMS) certification. This includes both experienced oxybate prescribers and those who have never previously prescribed an oxybate. Because of the risks of central nervous system depression and abuse and misuse, Lumryz is available only through a restricted program called the Lumryz REMS.

“2023 was transformational for Avadel defined by significant growth and continued execution of milestones critical to Avadel’s success, beginning with the FDA approval and receipt of Orphan Drug Exclusivity for Lumryz. The Lumryz launch has thus far been marked by robust demand and overwhelmingly positive feedback from the narcolepsy community, health care providers, and payers,” says Greg Divis, CEO of Avadel, in a release.

On the financial front, Avadel estimates net revenue from Lumryz sales to be approximately $19 million for the fourth quarter and $28 million for the full year of 2023. 

Since launch, Avadel also signed a contract with Emisar/Optum, adding to contracts established with Ascent/ESI and Zinc/CVS. Lumryz also was moved to preferred status within the CVS commercial formularies and Optum Select as of Jan 1.

Further expanding its potential impact, Avadel’s Supplemental New Drug Application for Lumryz in the pediatric narcolepsy population has been accepted by the FDA. A decision on this application is expected in September 2024. Pediatric patients currently represent about 5% of all oxybate-treated narcolepsy patients, according to Avadel.

The FDA’s approval of Lumryz was supported by the results from the REST-ON trial, which demonstrated statistically significant improvements in narcolepsy symptoms. The FDA also granted Lumryz seven years of Orphan Drug Exclusivity, recognizing its clinical superiority over existing twice-nightly oxybate products.